PREVALENCE OF POSTOPERATIVE NAUSEA AND VOMITING AND

ASSOCIATED FACTORS AMONG PEDIATRIC PATIENTS UNDERGOING

ELECTIVE SURGERY AT JIMMA UNIVERSITY MEDICAL CENTER,
JIMMA, SOUTH WEST ETHIOPIA, 2023.

BY; HANA YASIN MOLLA (ACCPMR3)

A RESEARCH PROPOSAL SUBMITTED TO JIMMA UNIVERSITY INSTITUTE OF

HEALTH, FACULTY OF HEALTH SCIENCES, SCHOOL OF ANAESTHESIA, IN
PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE SPECIALITY
CERTIFICATE IN ANESTHESIOLOGY

NOVEMBER, 2023

JIMMA; ETHIOPIA
 JIMMA UNIVERSITY INSTITUTE OF HEALTH, FACULTY OF
HEALTH SCINCE SCHOOL OF ANESTHESIA

PREVALENCE OF POSTOPERATIVE NAUSEA AND VOMITING AND

ASSOCIATED FACTORS AMONG PEDIATRIC PATIENTS UNDERGOING
ELECTIVE SURGERY AT JIMMA UNIVERSITY MEDICAL CENTER,
JIMMA, SOUTH WEST ETHIOPIA, 2023.

BY; HANA YASIN

ADVISORS 1. Dr. TARESSA DECHASA (MD, ASSISTANT PROFESSOR OF
ANESTHESIOLOGY)

A RESEARCH PROPOSAL SUBMITTED TO JIMMA UNIVERSITY INSTITUTE OF

HEALTH, FACULTY OF HEALTH SCIENCES, SCHOOL OF ANAESTHESIA, IN
PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE SPECIALITY
CERTIFICATE IN ANESTHESIOLOGY

NOVEMBER, 2023

JIMMA; ETHIOPIA
PROPOSAL SUMMARY
Background; Postoperative nausea and vomiting refers to the occurrence of nausea and
vomiting after a surgical procedure. It is a common complication following surgery and can
cause discomfort and distress to patients. It can vary in severity, ranging from mild discomfort to
more severe and persistent episodes. Postoperative nausea and vomiting is a multifactorial
phenomenon influenced by several various factors; patient related, surgical and anesthesia
related factors; identifying specific risk factors and developing predictive models can aid in risk
stratification and individualized management.

Objective: the aim of this study will be to assess the prevalence and associated factors among
pediatric patients undergoing elective surgery in Jimma university medical center, Jimma, South
West Ethiopia, 2023.

Methods; Institutional-based prospective cross-sectional study design will be conducted from

September 15, 2023, to December 15, 2023 on 122 patients which fulfill the inclusion criteria.
Structured and pretested questionnaires will be used to collect the data by interview and
document review. Data will be collected by 2 trained BSc nurses who are working at recovery
and Anesthesia residents & 01 supervisor. Data will be entered into Epi-Data version 3.1 and
exported to SPSS version 25 for further analysis. Logistic regression analysis method will be
used to show an association between dependent variable and predictor variables. During
bivariate logistic regression analysis variables which has p≤0.25 will be considered to declare
candidate variables for multivariate logistic regression. Multivariate logistic regression will be
done to control for confounders and to identify factors independently associated with the
outcome variable among patients done operated at Jimma University Medical Center. The level
of statistical significance will be declared at P < 0.05 with a 95% CI of AOR.
Budget and work plan: To conduct the study a total budget of 25,000.25 ETB will be required.
Keywords: Postoperative nausea and Vomiting, pediatric patients, elective surgery, JUMC,
Jimma Ethiopia
ACKNOWLEDGEMENTS
Before anything else, I am indebted to my Creator who was with me through each and every step
of the way.

I am also thankful to the Department of Anaestesia institute of health, Jimma University for
providing me with this opportunity to undertake this study. I am grateful to my advisor Dr
Taressa Dechassa for his constant guidance; to the staff of Jimma medical center for their
unlimited assistance during the collection of data.
TABLE OF CONTENTS
Proposal summary......................................................................................................................................iii
Acknowledgements.....................................................................................................................................iv
List of tables................................................................................................................................................7
List of Figures.............................................................................................................................................8
Lists of Abbreviations.................................................................................................................................9
1. Introduction.......................................................................................................................................10
1.1. Background................................................................................................................................10
1.2. Statement of the problem...........................................................................................................11
1.3. Significance of the study............................................................................................................12
2. Literature review...............................................................................................................................14
2.1. Prevalence of postoperative nausea and vomiting......................................................................14
2.2. Factors associated with PONV..................................................................................................15
2.3. Conceptual Framework..............................................................................................................18
...............................................................................................................................................................18
3. Objectives..........................................................................................................................................19
3.1. General Objective......................................................................................................................19
3.2. Specific Objectives....................................................................................................................19
4. Methods and Materials......................................................................................................................20
4.2 Study design....................................................................................................................................20
4.3 Population........................................................................................................................................20
4.3.1. Source population....................................................................................................................20
4.3.2. Study population:.....................................................................................................................20
4.4 Eligibility Criteria............................................................................................................................20
4.4.1 Inclusion criteria:......................................................................................................................20
4.4.2 Exclusion criteria:.....................................................................................................................20
4.5. Sample size determination and sampling procedure.......................................................................20
4.5.1. Sample size determination.......................................................................................................20
4.5.1. Sampling Procedures...............................................................................................................21
4.6. Study variables...............................................................................................................................21
4.6.1. Dependent variable..................................................................................................................21
4.6.2. Independent Variables.............................................................................................................21
 4.7. Operational Definitions..................................................................................................................22
4.8. Data collection tools and procedures..............................................................................................22
4.9. Data quality assurance....................................................................................................................23
4.10. Data processing and Analysis.......................................................................................................23
4.11. Ethical considerations...................................................................................................................24
4.12. Plan for dissemination of results...................................................................................................24
5. Work Plan..............................................................................................................................................25
6. BUDGET.............................................................................................................................................26
References.................................................................................................................................................28
ANNEX.....................................................................................................................................................31
Annex I - Information Sheet..................................................................................................................31
Annex II- English Version.....................................................................................................................31
LIST OF TABLES
Table 1: Work plan for proposed activities to assess prevalence of postoperative nausea and
vomiting among patients undergoing elective surgery at JUMC, Jimma, South West, Ethiopia,
2023...............................................................................................................................................22
Table 2; Budget Breakdown for proposed activities to prevalence of postoperative nausea and
vomiting among patients undergoing elective operation Jimma, South West, Ethiopia, 2023.....23
LIST OF FIGURES
ASA American Society of Anesthesiologists Figure 1; Adapted conceptual
framework by reviewing different
AOR Adjusted odd ratio
literatures to assess the prevalence
BMI Body Mass Index of PONV and associated factors
among patients undergoing
CI Confidence Interval
elective surgery in JUMC, south
COR Crud odd ratio west Ethiopia, 2023....................18
DC Data collector
GA General Anesthesia
GC Gregorian calendar LISTS OF
JUMC Jimma University Medical Center ABBREVIATIONS
OR Odd ratio
PACU Post-Anesthesia care unit
PONV Postoperative Nausea and Vomiting
 1. INTRODUCTION
1.1. Background
Postoperative nausea and vomiting (PONV) is defined as any nausea, retching, or vomiting
occurring during the first 24 –48 h after surgery in inpatients (1). PONV are among the most
common adverse events following surgery, anaesthesia and opioid analgesia, although; usually
of minor medical impact, they can cause a lot of distress, lead to delayed hospital discharge and
increased use of resources (2). It is estimated that up to 70% of the surgical patients may
experience PONV depending on the type of surgery and patient-specific factors (3). It is not only
leads discomfort and distress to patients but also leads to adverse consequences such
dehydration, electrolyte imbalances, wound dehiscence, delayed recovery, prolonged hospital
stays and increased health care costs (4).

The pathophysiology of PONV is complex and involves various mechanisms, it is believed to

result from the activation of multiple neurotransmitter systems, including the serotonergic and
dopaminergic systems (4). The release of these neurotransmitters in the central nervous system
leads to stimulation of the vomiting center in the brainstem, triggering the emetic response (5).
There are also other factors to enhance the occurrence of PONV such as inflammation, gut
dysmotility, and the individual's susceptibility to motion sickness may also contribute to the
occurrence of PONV (4,5).

PONV is caused primarily by the use of inhalational anesthesia and opioid analgesics. PONV is
also increased by several risk predictors, including a young age, female sex, lack of smoking,
and a history of motion sickness. Genetic studies are beginning to shed light on the variability in
patient experiences of PONV by assessing polymorphisms of gene targets known to play roles in
emesis (serotonin type 3, 5-HT3; opioid; muscarinic; and dopamine type 2, D 2, receptors) and the
metabolism of antiemetic drugs (e.g., ondansetron) (6).

Drugs to treat PONV generally referred to as anti-emetics, some have more anti-nausea and less
anti-vomiting effects, whilst others have less anti-nausea and more anti-vomiting effects.
Pharmacological treatment of PONV is common, using a wide range of drugs, but with variable
efficacy. The drugs are generally grouped according to the type of receptor at which they act,
usually as an antagonist. The following text describes the various groups of drugs conventionally
used in the treatment of PONV, and their contraindications (2).
Its fact that PONV is the one common complications after Anesthesia because most of surgical
interventions are for benign conditions, morbidities or complications happening to patients is the
major concern for the patients, physicians as well as their relatives regarding to PONV. Although
it is often self-resolving, most patients complain it as more uncomfortable than postoperative
pain (7,8).

Every health care providers must be targeted on treating patients without any complications with
a smooth postoperative encounter and reducing the economic burden related to treatment of
unwarranted complications. Since PONV is one of the major contributing factors for patient
discomfort, postoperative morbidity and mortality as well as economic burden due to the
unintended longer stay in the hospital and its cost. In order to prevent PONV, it’s vital to study
the prevalence and associated factors.

1.2. Statement of the problem

Tens of millions of patients are estimated to receive general anesthesia in the process of
surgery through intravenously, intramuscularly and through inhalation or through gas. General
anesthesia has side effects on patients like nausea (10-40%), vomiting (10-20%), incision pain
(30%), and sore throat during and within 24 hrs. after surgery (25%). Nausea and vomiting can
be very dangerous because it can cause asphyxia, hypoxia, and hypercapnia because gastric
contents can cause aspiration, and there are 1:100,000 cases of death caused by general
anesthesia (9).

PONV is still high even though the anesthesia providers use prophylactic anti emetics it reported
up to 25–30% in American Society of Anesthesiologists (ASA) class 1 and 2 but may reach up to
80% in ASA 3 patients; whereas the incidence of PONV in general surgical population reported
up to 30% and as high as 80% in high risk cohorts (10,11). The incidence of PONV depends on
the surgical procedure and disease condition (3). Furthermore, PONV is not only causes distress
to patients but also had the economic burden associated with it including increased medication
and resource utilization, adds to the healthcare costs (12).

PONV is a multifactorial phenomenon influenced by several various factors of patient related,

surgical and anesthesia related factors; identifying specific risk factors and developing predictive
models can aid in risk stratification and individualized management. Among patient related
factors being female gender, younger age, non-smoking status, history of motion sickness, and
personal or family history of PONV have been associated with an increased risk of PONV and
understanding patient-specific factors that contribute to PONV will facilitate the selection of
appropriate antiemetic interventions and optimization of preventive measures (13). Among
surgical related factors certain types of surgeries have a higher incidence of PONV like
gynecological procedures, ear, nose, and throat surgeries, and laparoscopic surgeries (14).

The magnitude of PONV is vary from country to country like a systematic review which
included a total of 23 studies that were performed on 22,683 people from 11 countries revealed
that the prevalence of PONV, nausea, and vomiting was 27.7%, 31.4%, and 16.8%, respectively;
the prevalence of PONV was higher during the first 24 h in European countries (15). Another
study conducted in Turkey showed that of all patients, 59.3% experienced nausea and 39% had
postoperative vomiting (16). The study done at tertiary care hospital in northwestern Tanzania
shows that the incidence of postoperative nausea and vomiting was 41.4% (17). In Ethiopia there
is no national data on prevalence of PONV however, a study done in university of Gondar,
Ethiopia showed that the prevalence of postoperative nausea and vomiting was 36.2% within 24
hours after operation (18).

Knowing the magnitude of postoperative nausea and vomiting is crucial for ensuring patient
safety, planning appropriate treatments, improving patient comfort and satisfaction, allocating
resources efficiently, and advancing research and quality improvement efforts in PONV
management. So the aim of this study will be to determine the level of postoperative nausea and
vomiting and associated factors among pediatric patients undergone elective surgery in Jimma
University Medical Center (JUMC).

1.3. Significance of the study

Because PONV is one of the major problem in post-operative patients, studying on this area will
have an indispensable importance for both the patient as well as the health professional. This
study will provide insights into prevalence of PONV, risk factors and management strategies for
PONV who have undergone elective surgery. This finding will have positive contribution
regarding the prevention and management of PONV in patients underwent elective surgery by
providing evidence-based recommendations in the study setting.

Therefore, the results of this study will be used for the improvement of patients from developing
PONV and management strategies among patients underwent elective surgery. It may also will
have positive contribution for policy makers to design implementation to minimize the
magnitude of PONV by identify the contributing factors. In general this study will give
information to improve patient care, guiding clinical decision-making, identifying risk factors,
evaluating treatment efficacy, may driving quality improvement initiatives, assessing cost-
effectiveness, and advancing scientific knowledge during perioperative and postoperative care.
 2. LITERATURE REVIEW
2.1. Prevalence of postoperative nausea and vomiting
PONV is the most frequent side effects of anesthesia and surgery, it can range in severity from
mild, transient symptoms to more persistent and severe cases. According to study conducted in
Pakistan khyber teaching hospital revealed that PONV was more common in the propofol group
(70%) than in the dexamethasone group (40%) particularly in the first six hours after surgery
(19). According to study conducted in Japan among pediatric patients underwent surgery
investigated the overall incidence of POV within 24 hours after anesthesia was 45.9% in the
lidocaine group and 63.4% in the control group The incidence of PONV within 24 hours after
anesthesia was 3.73% in the lidocaine group and 4.87% in the control group (20).

Based on study conducted in India revealed that the overall prevalence of PONV was reported
among 25.6% patients (21). Based on study conducted in Nepal revealed that among 200
patients, postoperative nausea and vomiting were seen in 28 (14%) (9.19-18.81, 95% Confidence
Interval) of which seven (25%) of the patients experienced post-operative vomiting as well (22).
Similarly another cross sectional study conducted in Turkey among pediatric patients revealed
that the incidence of PONV was 25% (23). According to study conducted in Santiago, Chile
investigated that During the first 24 h postoperative, 41 of 50 patients in Group 1 (82%) and 31
of 50 patients in Group 2 (62%) experienced at least one episode of retching, vomiting, or both
(incidence decreased by 24%) (24). Another prospective cohort study conducted in Columbia
showed that the overall incidence of postoperative vomiting was 18.95% (95% CI: 13.32 -
24.57), with a higher incidence at home vs. hospital (12.63% vs. 9.47%) (25).

Similarly according to study conducted in South Korea revealed that the incidence of PONV and
postoperative vomiting was 17.9%/17.9%% and 12.8%%/10.2%% (Group S/ Group R) at the
respective time points; values were comparable between the groups (26). Another cross
sectional prospective study done in North West Tanzania showed that the incidence of
postoperative nausea and vomiting was 41.4% (17). A study conducted in Asmara, Eritrea
showed that the overall incidence of PONV in ENT Orrota National Referral Hospital was
32.8%. Out of the occurrence of PONVs, the highest percentage was vomiting (48.8%) while
nausea, retching as well as nausea and vomiting together had 17.1% (27). Another local study
conducted at university of Gondar showed that the overall incidence of PONV was 36.2% (18).
According to cross sectional study conducted in Debre Berhan referral Hospital revealed that the
incidence of postoperative nausea, vomiting and nausea and vomiting were 79 (19.85%), 16
(4.02%) and 87(21.86%) respectively (28). A study done at Jimma university medical center
showed that the incidence of postoperative nausea and vomiting was 27.4% (29).

2.2. Factors associated with PONV

According to study conducted in Cali, Colombia revealed that the variables associated with
PONV were age (odds ratio [OR] = 0.98, 95% confidence interval [CI] 0.96–0.99, P=0.013) and
being female (OR=3.02, 95% CI 1.66–5.47, P<0.032) (30). Another study conducted in
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mahidol University,
Bangkok, Thailand showed that the independent predictor variables were having age < 30 years,
history of PONV and/or motion sickness, and anesthesia duration > 4 h. Furthermore, the
number of risk factors was proportional to the incidence of PONV (31). Based on a cross
sectional study conducted at tertiary care hospital, India revealed that being female gender, non-
smokers and occurrence of PONV (CI 95%, p <0.001, 0.005, respectively). PONV was seen to
be more common in patients with history of PONV in prior surgeries, in patients who underwent
surgery under general anaesthesia and in patients where opioids were used in the post-operative
period (95% CI, p < 0.001, 0.001 and 0.001 respectively). General, laparoscopic, abdominal,
orthopaedic, obstetric, breast and urological (32).

According to a retrospective cohort study conducted in academic medical center in Seoul, South
Korea entitled as effects of sugammadex versus neostigmine on postoperative nausea and
vomiting after general anesthesia in adult patients investigated that Multivariable logistic
regression analysis showed that sugammadex use was significantly associated with overall and
early PONV occurrence (overall: OR, 0.87; 95% CI, 0.77–0.98; P=0.023; early: OR, 0.81; 95%
CI, 0.68–0.96; P=0.013). Given that there were no significant interactions among sugammadex
use and type of general anesthesia for the overall and early PONV occurrence, their interaction
term was not included in these models (32). Similar study conducted in Tagore Medical College
& Hospital, Dr. M.G.R. Medical University, Chennai, Tamilnadu, India investigated that female
sex is more prone to have PONV which was followed by laparascopy (20%) and ENT
procedures (15%) in the descending order of PONV risk surgical procedures (33).
Similar study conducted in China revealed that were 156/1,670 (9.3%) PONV cases, and the
female and male incidence in recruited cases was 12.0% and 6.0%, respectively. Analyses on
perioperative data of them identified that female gender [adjusted odds ratio (AOR) ¼ 2.060, P <
0.001], operation time >1 h (AOR ¼ 1.554, P ¼ 0.011), postoperative pain at rest (AOR ¼
1.909, P ¼ 0.013) and postoperative pain during activities (AOR ¼ 3.512, P < 0.001) were
independent risk factors of PONV following ambulatory surgery (34). According to study
conducted in Japan showed that the major risk factor for PONV was the use of volatile
anesthetics. Patients in whom anesthesia was maintained by volatile anesthetics were 13.35 times
more likely to have PONV than those in whom total intravenous anesthesia was induced
(P<0.001) (35). A study done in Taiwan showed that among predictor variables associated with
PONV female gender (OR 4.89) is the strongest predicting factor, followed by a less potent
predicting factor more intraoperative opioid consumption (OR 1.07) which favor more PONV.
More intraoperative crystalloid supply (OR 0.71) and a higher body weight (OR 0.9) favor less
PONV (36). Similar study conducted Hokkaido University, Japan revealed that Total intravenous
anesthesia with propofol was a significant depressant factor for early PONV (adjusted odds ratio
[AOR] = 0.340, 95% confidence interval [CI] = 0.209–0.555) and late PONV (AOR = 0.535,
95% CI = 0.352–0.814). The administration of a combination of intraoperative antiemetics (vs.
no administration) significantly reduced the risk of early PONV (AOR = 0.464, 95% CI = 0.230–
0.961). Female sex and young age were significant risk factors for late PONV (AOR = 1.492,
95% CI = 1.170–1.925 and unit AOR = 1.033, 95% CI = 1.010–1.057, respectively (37).

A study conducted in Tanzania, showed that Age group 21-30, female gender, history of PONV,
general anaesthesia and intraoperative pethidine were the main predictors of PONV (p < 0.001)
(17). According to study conducted in Malawi investigated that the overall incidence of
postoperative nausea and vomiting was 29.6%. It was higher among women than men. Patients
with motion sickness had the highest incidence of postoperative nausea and vomiting (78.6%)
followed by those with migraine (73.3%). Patients whose intraoperative systolic blood pressure
fell <80 mmHg had an incidence of 71.4% and those who received postoperative opioids had an
incidence of 37.7% (38).

A cross sectional study done at University of Gondar revealed that factors that were associated
with postoperative nausea and vomiting were history of motion sickness (AOR = 6.0, CI = 2.51–
14.49), previous history of postoperative nausea and vomiting (AOR = 13.55, CI = 6.37–28.81)
and long duration of surgery (AOR = 10.1, CI = 3.97–25.92) (18). According to study conducted
in Debre Berhan Referral hospital revealed that factors that have an association with
postoperative nausea were female sex, previous history of PONV, history of motion sickness,
duration of anesthesia >60 min, use of postoperative and obstetrics and gynecology surgery. In
addition, factors that were associated with postoperative vomiting were female sex, previous
history of PONV, history of motion sickness, duration of anesthesia >60 min, use of
postoperative opioids and obstetrics and gynecology surgery (28). A study conducted at Jimma
University Medical Center revealed that variables that have associated with PONV were female
sex (AOR = 4.065 (2.090–7.906), history of motion sickness (AOR = 2.836 (1.582–5.083),
Gynecologic type of surgery (AOR = 3.782 (1.156–12.373), long duration of anesthesia (> 60
min) (AOR = 2.974 (1.491–5.933) and administration of post-operative opioids (AOR = 2.333
(1.221–4.457) were considered as independent predictors of postoperative nausea and vomiting
at P-value < 0.05 (29).
 2.3. Conceptual Framework
Postoperative characteristics of patients Preoperative related
 Time of PONV occurred after operated characteristics
 Use of postoperative analgesic in the PACU  BMI
Socio  Use of postoperative analgesic in the wards  ASA class
demographic
 History of having
characteristics
previous surgery
 age  History of having
 sex previous PONV
 Family history of PONV
 History of having motion
sickness
PONV  Use of opioid before
operation

Intraoperative and postoperative characteristics of patients

 premedicated for PONV √ types of surgery
 given antibiotics √ duration of surgery
 types of anaesthesia √ intraoperative drug and dose
 types of induction agent √ having any episode of intraoperative hypotension

Figure 1; Adapted conceptual framework by reviewing different literatures to assess the

prevalence of PONV and associated factors among patients undergone elective surgery in
JUMC, south west Ethiopia, 2023.
3. OBJECTIVES
3.1. General Objective
 To assess the prevalence of postoperative nausea and vomiting and associated
factors among pediatric patients undergoing elective surgery at Jimma University
Medical Center, Jimma, South West Ethiopia, 2023.
3.2. Specific Objectives
 To determine the prevalence of PONV among pediatric patients undergoing
elective surgery at Jimma University Medical Center, Jimma, South West
Ethiopia, 2023
 To identify factors associated with postoperative nausea and vomiting among
pediatric patients undergoing elective surgery at Jimma University Medical
Center, Jimma, South West Ethiopia, 2023
 4. METHODS AND MATERIALS
Jimma University Medical Center is a referral hospital found in Jimma city, southwest Ethiopia
which is around 350km from the capital city, Addis-Ababa. It started as a referral and specialized
medical center for about 15 million populations in the catchment areas of southwestern Oromia,
Gambella, and South nations and nationalities regional state. Currently, it is assumed to be
serving even a higher population because of the influx of displaced people and new visitors from
neighboring South Sudan. It provides a broad range of medical services to patients of all age
groups. It also serves as a teaching hospital to several medical specialties, dental medicine,
nursing, midwifery, public health, pharmacy, anesthesia, and medical laboratory students in both
undergraduate and post-graduate programs. The hospital has 800 beds capacity. JUMC has 10
major and 3 minor Operation Room tables with 7 post-operative anesthesia care unit (PACU)
beds. The hospital has 21 fully functional NICU beds, 4 PICU tables, and 12 adult ICU beds as
multipurpose for both medical and surgical cases. The study period will be from June 15, 2023,
to August 15, 2023.

4.2 Study design

 A facility based Cross-sectional study design will be employed.
4.3 Population
4.3.1. Source population
 All pediatric patients (0-14 years) undergone elective surgery at Jimma University Medical
Center
4.3.2. Study population:
Selected patients (0-14 years) underwent elective surgery at Jimma University Medical Center
4.4 Eligibility Criteria
4.4.1 Inclusion criteria:
 All patients (0-14 years) who are undergone elective surgery in Jimma University Medical
Center.
4.4.2 Exclusion criteria:
 Patients undergone emergency surgery
  Patients discharged before 24 hours of surgery
 All patients admitted to ICU
 Patients on chemotherapy
4.5. Sample size determination and sampling procedure
4.5.1. Sample size determination
A single population proportion formula will be used to calculate the sample size by considering
the following assumption: - p (prevalence of the problem in the previous study) as the prevalence
of postoperative nausea and vomiting done on Postoperative nausea and vomiting and associated
factors among elective surgical patients at Tikure Anbessa Specialized Teaching Hospital
(TASH) which was 7.8% specifically in 0-14 years of patients (39) and by considering 95%
confidence interval (CI) with the level of precision zα/2 = 1.96, p-value 0.05, the margin of error
0.05.

n= (zα/2)2pq.
d2
n = (1.96)2 (0.078) (0.922)
(0.05)2
n =110.51
By; adding 10 % of the non-response rate (by considering lost or incomplete sheets) giving a
total sample size of n = 122
Where, n= sample size, d = marginal error, p = prevalence and q=1-p
4.5.1. Sampling Procedures

Convenient sampling technique will be used to select the study participants and the target
population will be all elective surgical pediatric patients operated at JUMC for three consecutive
months. The sampling frame will be determined from the OR registration log book, however due
to the small number of sample size convenient sampling technique will be applied to select the
study participants for three consecutive months.
4.6. Study variables
4.6.1. Dependent variable
 Postoperative nausea and vomiting
4.6.2. Independent Variables
Socio-demographic related characteristics; age of the respondent, sex of respondent

Preoperative related characteristics; weight of the respondent, height of the respondent, ASA
class, history of having previous surgery, history of having previous PONV, family history of
PONV, history of having motion sickness and use of opioid before operation

Intraoperative and postoperative characteristics of patients; premedicated for PONV, given

antibiotics, types of anesthesia, types of induction agent, types of surgery, duration of surgery,
intraoperative drug and dose, having any episode of intraoperative hypotension

Postoperative characteristics of patients; having postoperative nausea and vomiting, time of

PONV occurred after operated, use of postoperative analgesic in the PACU, use of postoperative
analgesic in the ward.

4.7. Operational Definitions

The American Society of Anesthesiologists (ASA): Physical Status grading system simply to
assess the degree of a patient’s "sickness" or "physical state" prior to selecting the anesthetic or
prior to performing.
Elective surgery: is surgery done before on set (appearance) of any complication that might
constitute urgent indication
Early post-operative time: early post-operative time is used starting from the time when the
patient reaches to post anesthesia care unit to six hours.
Late post-operative time: time considered from six hours of patient reached to post anesthesia
care unit to 24 hours.
Nausea: is an unpleasant sensation associated with the urge to vomit, characterized by excessive
salivation and disturbing feeling.
Post-operative nausea and vomiting: any nausea, retching or vomiting occurring in the first 24
hours after surgery.
Motion sickness; feeling of nausea, dizziness with or without vomiting during travel (car, plane,
train).
Hypotension: a drop in blood pressure by 20% systolic or 10% diastolic from the baseline
4.8. Data collection tools and procedures
The data will be collected by face to face interview of the participants and document review by
five trained BSc Nurses by using a pretested and structured ‘Afaan Oromo and Amharic’
language versions which is adapted from reviewing existed literatures. The data collection tools
consist of Part 1: Socio-demographic characteristics such as age, sex and residence Part 2:
preoperative related characteristics; such as weight of the respondent, height of the respondent,
ASA class, history of having previous surgery, history of having previous PONV, history of
having motion sickness and take opioid before operation Part 3: intraoperative related factors
such as; premedicated for PONV, given antibiotics, types of anaesthesia, types of induction
agent, types of surgery, duration of surgery, intraoperative drug and dose, having any episode of
intraoperative hypotension. Part 4: postoperative related characteristics such as having
postoperative nausea and vomiting, time of PONV occurred after operated, take postoperative
nausea and vomiting in the PACU, taking postoperative nausea and vomiting in the ward.

4.9. Data quality assurance

To assure the quality of data, the following measure will be undertaken. A standard data
collection instrument will be used. The questionnaire will be pretested on 5% of the sample size
out of the study setting which is in Agaro General Hospital and the clarity of language will be
checked. The principal investigator will also closely supervise the activity daily. At the end of
each data collection day, the principal investigator will check the completeness of the filled
questionnaires and whether recorded information makes sense to ensure the quality of the data
collected. There will be meeting whenever necessary with the data collectors so that any
ambiguity will be cleared by discussion.
4.10. Data processing and Analysis
The collected data will be checked for completeness by manually before entry into computer.
Then the questionnaire will be coded and it will be entered in to Epi-data version 3.1. Then the
data will be exported to SPSS version 25 for further analysis. Frequency, mean, median, mode,
cross-tabulation, and standard deviation will be used to summarize the descriptive statistics. And
tables and graphs will be used for data presentation. Bivariate logistic regression analysis will be
used to select the candidate variables at a p-value less than or equal to 0.25. Variables found to
have an association with the dependent variable (p-value ≤0.25) will be entered into multivariate
logistic regression models for further analysis and variables having a P-value of less than 0.05
will be considered as significantly associated variables with the dependent variable. The degree
of association between dependent and independent variables will expressed by using an AOR
with a 95% confidence interval.

4.11. Ethical considerations

Ethical clearance will be obtained from the Institutional Review Board (IRB) of Jimma
University Institute of Health. Additionally, permission letters will be obtained from JUMC
clinical director office. Permission letter will be obtained from school of Anaestasia, Jimma
University before the commencement of the study.
4.12. Plan for dissemination of results
The finding of this study will be disseminated to Jimma University Faculty of Medical and
Health Sciences, the school of Anaestasia and other relevant stakeholders. Attempts will also be
made to publish it in peer-reviewed scientific journals.

5.
 5. Work Plan
Table 1: Work plan for proposed activities to assess prevalence of postoperative nausea and
vomiting among pediatric patients undergone elective surgery at JUMC, Jimma, South West,
Ethiopia, 2023.

S.No Activities Respons Time

ible
June July Augu Septe Octo Nove Decem Januar
person st mber ber mber ber y
2023 2023
2023 2023 2023 2023 2023 2024
1 Topic selection PI
2 Proposal PI
preparation
3 PI
First draft submission

4 Final proposal PI
5 Collection PI

of budget material
and obtaining an
ethical review letter
6 Data collection DC

7 Data analysis and PI

interpretation
8 Report writing PI
9 First draft PI
submission
10 Feedback discussion PI
with an
advisor
11 Paper submission PI
12 Defense PI
6. BUDGET
Table 2; Budget Breakdown for proposed activities to prevalence of postoperative nausea and
vomiting among patients undergone elective operation Jimma, South West, Ethiopia, 2023.

S. Budget Unit Unit price Multiplying Total

N measurement (ETB) factor
category Price

1. Personnel

Data Person 60*5 60 18000

collectors

Secretarial Person 165*1 6 990

work

Subtotal 19,990

2. Supplies Cost per item Number

Questionnaire Paper 3 birr*3 300 900

duplication

Pencil Piece 2.50 birr 10 25

Eraser Piece 2.50 birr 5 12.5

Pen Piece 20 3 60

Printing and Piece 3 birr for printing, 3copy*60 840

binding 100birr for binding pages, 3 binder

Subtotal 1837.5

3 Training

Hall rent Room 500/day 1 500

Coffee and tea Cup 100 per 4participants*1 400

participant per
 day

Subtotal 900

4 Total 1+2+3 22727.5

5 10% contingency 10% of total 2272.75

6 Grand total 1+2+3+4+5 25,000.25

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ANNEX
Annex I: English version information sheet and Questionnaire Consent Form
This questionnaire is used as a guide to collect information for the data collectors. It is designed
to assess prevalence of postoperative nausea and vomiting and associated factors among
pediatric patients undergoing elective surgery in JUMC, Jimma, South West Ethiopia, 2023.
Hello! My name is------------------------------and I am involved in a research study at Jimma
University Medical Center. The purpose of this study is to gather information about the
prevalence and risk factors of postoperative nausea and vomiting (PONV) in pediatric patients
who have undergone elective surgery under anesthesia at JUMC. I am working with Dr. Hana
Yasin, the principal investigator, as part of specialization in anesthesiology, critical care, and
pain medicine.
I would like to invite you to participate in this study by providing some information. Your
participation will greatly contribute to our understanding of PONV and help us improve
management and prevention strategies in the future. Participating in this study will not have any
risk or harm associated with data collection. I assure you that all the information you provide
will be kept strictly confidential and no personal identifiers will be included.
If you agree to participate, please indicate your consent by selecting among options below.
A/ agree B/ Disagree
Once you have agreed, the interview will begin, and I will ask you a series of questions. If you
have any questions about the study, please feel free to contact me at 0916105716 or
hachoyass@gmail.com.
Thank you for considering participating in this research. Your contribution is highly appreciated.
Questionnaire: Code________
Name of data collector _____________________________signature___

Annex II- English Version

Part one; Demographic and socio-economic characteristics questions
S.N Questions Responses Remark
Medical record number _____________________
101 Age of the respondent __________in years
102 Sex of the respondent 1. Male
2. Female
Part two; Preoperative related characteristics
201 Weight In____________Kg.
202 Height In _______________cm
203 ASA class _________________
204 Does He/she have history of previous 1. Yes
surgery? 2. No
205 If yes for Q204, does he/she have history 1. Yes
of PONV 2. No
206 Is there any history of PONV in the 1. Yes
parents or siblings? 2. No
207 Does He/she have history of motion 1. Yes
Sickness? 2. No
208 Is He/she taking opioid in the last 24hrs 1. Yes
preoperatively? 2. No
209 If yes for q207 please document type of _________________________?
opioid?
Part Three- intraoperative related characteristics
301 Did the patient premedicated for PONV? 1. Yes
2. No
302 f yes for Q 301, what type and dose of _________________
the drug given?
303 Was prophylactic antibiotics given? 1. Yes
2. No
304 If yes for Q303 what antibiotics was _____________________
given?
305 Type of Anesthesia 1. GA with LMA
2. GA with ETT
3. Regional
306 If for q305 is regional Anesthesia, was 1. High spinal
there any complication related to 2. Total spinal
regional anesthesia 3. Partial block requiring
supplemental anesthesia
307 Induction agent 1. Propofol
2. Thiopental
3. Ketamine
4. Others specify_______
308 Types of surgery 1. General surgery
2. Neurosurgery
3. Ophalmologic
4. ENT
5. Orthopaedics
6. Others (maxillofacial,
plastic...)
309 Duration of surgery In minute_____________
310 Intraoperative analgesia (drug and dose) ______________
Q311 Did the patient have any episodes of intra 1. Yes
operative hypotension? 2. No
Q312 If yes for Q 10, how many episodes does _____________
he/she had?
Part four; postoperative related characteristics
401 Did the patient have post-operative 1. Yes
nausea or vomiting? 2. No
402 If yes for Q 401 what he/she experienced 1. Nausea only
2. Vomiting only
3. Both
403 When did it occurred? 1. Intraoperative
2. 0-6Hrs Post-operative
3. ≥7Hrs post-operative
404 Post-operative analgesia in the PACU ________________in gm
405 Post-operative analgesia in the ward ________________in gm

Thank you for your participation!