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Effect of Paracetamolprednisolone Versus Paracetamolibuprofen On Post-Operative Recovery After Adult Tonsillectomy
Effect of Paracetamolprednisolone Versus Paracetamolibuprofen On Post-Operative Recovery After Adult Tonsillectomy
Effect of Paracetamolprednisolone Versus Paracetamolibuprofen On Post-Operative Recovery After Adult Tonsillectomy
PII: S0196-0709(18)30190-X
DOI: doi:10.1016/j.amjoto.2018.03.028
Reference: YAJOT 2004
To appear in:
Received date: 26 February 2018
Please cite this article as: Alexandra C.G. Fonseca, Margaret I. Engelhardt, Zhen J.
Huang, Zi Yang Jiang, Sancak Yuksel, Soham Roy , Effect of changing postoperative pain
management on bleeding rates in tonsillectomy patients. The address for the corresponding
author was captured as affiliation for all authors. Please check if appropriate. Yajot(2017),
doi:10.1016/j.amjoto.2018.03.028
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Title
Authors
Alexandra C.G. Fonseca, BSa; Margaret I. Engelhardt, BSa; Zhen J. Huang, MD, MBAa; Zi Yang Jiang,
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McGovern Medical School at the University of Texas Health Science Center at Houston, Department of
This research did not receive any specific grant from funding agencies in the public, commercial, or not-
for-profit sectors.
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Correspondence
Correspondence, reprint requests, and proofs should be sent to Soham Roy, MD, Department of
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Otorhinolaryngology, University of Texas Health Science Center at Houston McGovern Medical School,
6431 Fannin Street, Houston, TX 77030. E-mail: soham.roy@uth.tmc.edu, telephone: 713-500-5410, fax:
713-383-3727.
Notes
Abstract
including the impact of narcotic versus nonsteroidal anti-inflammatory drug (NSAID) postoperative pain
management.
Materials and Methods: A retrospective review was performed of tonsillectomies conducted at a single
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institution between 1/1/2013 and 1/1/2017. The rates of PTH and subsequent intervention were
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calculated. These were categorized into patients having surgery pre- and post-July 1, 2015, the former
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group receiving narcotics and the latter ibuprofen with acetaminophen.
Results: Of 1351 total tonsillectomies, 3.04% had PTH requiring return to the hospital. 0.74% required
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no further surgical intervention, whereas 2.30% required secondary surgical control. The bleed rate prior
to July 2015 was 3.15%, with 1.05% non-surgical bleeds and 2.10% requiring surgery. Post-July 2015,
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the bleed rate was 2.92%, with 0.44% non-surgical bleeds and 2.49% requiring surgery. There were no
statistically significant differences between the two groups with respect to overall, non-surgical, and
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surgical hemorrhage rates (p>0.05). Of the total bleeds, the need for secondary surgery in the narcotic
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group was 66.7% and 85% in the NSAID group (p=0.18). During the study period, 36 patients with PTH
had their initial tonsillectomy performed at outside institutions; 53% required surgical intervention.
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patients, often requiring surgical intervention. This review found no increased bleeding risk associated
Keywords
Level of Evidence
2b
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Introduction
Tonsillectomies remain one of the most commonly performed surgeries, with more than half a million
performed each year in patients under the age of fifteen1. Post-tonsillectomy hemorrhage (PTH) and
respiratory complications are among the most common complications following surgery2; in light of these
risks, surgeons must choose a pain regimen that provides adequate analgesia while maintaining an
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acceptable safety profile. In August 2012, the U.S. Food and Drug Administration contraindicated the
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use of codeine in children for pain management following tonsillectomy due to the risk of respiratory
depression2. Continued concern over narcotic-induced respiratory depression resulted in a shift away
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from the use of all narcotics in pediatric tonsillectomy patients in 2015 in favor of a regimen of
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acetaminophen plus ibuprofen. Our study sought to determine the rates of PTH and need for subsequent
intervention at a quaternary medical center as a means to evaluate the impact of narcotic versus
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nonsteroidal anti-inflammatory drug (NSAID) postoperative pain management on hemorrhage risk.
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A retrospective review was performed of all tonsillectomies conducted at a single institution between
January 1, 2013 and January 1, 2017. These were categorized into patients having surgery pre- and post-
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July 1, 2015. The cohort of patients treated prior to July 1, 2015 were prescribed narcotics as adjunctive
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management for postoperative pain (acetaminophen with hydrocodone). This group was compared to
those treated after July 1, 2015, who were given alternating acetaminophen and ibuprofen for pain
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without an added narcotic option. This regimen shift at our institution was applied to both adult and
pediatric patients. The rates of PTH and subsequent surgical intervention or non-operative management
were calculated. Risk ratios with associated 95% confidence intervals (95% CI) and p-values were
calculated by dividing the bleeding risk resulting from NSAID use by the bleeding risk of narcotics in
Results
During the 4-year study period, a total of 1351 tonsillectomies were performed at our institution by 18
otolaryngologists (Table 1). The majority (71%) of these tonsillectomies were conducted by three high
volume pediatric otolaryngologists. For this review, only total tonsillectomy procedures were considered,
with or without other surgical procedures including adenoidectomy, tympanostomy tube placement or
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other procedures. Intracapsular tonsillectomy procedures were excluded. 1105 (81.8%) of the
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tonsillectomies were performed on children under the age of 18, and 246 (18.2%) were performed on
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adults. Patient age at surgery ranged from 3 months to 83 years, with an average age of 11.8 years. Of
the total, 41 patients (3.04%) had PTH requiring return to the hospital. Of these patients, 21 (51.2%)
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were male and 20 (48.8%) were female. Age at the time of initial surgery for patients experiencing PTH
ranged from 2 to 51 years, with an average age of 13.5 years. 32 (78.1%) of these patients were children
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and 9 (22.0%) were adults. The risk of PTH in the pediatric population was 2.89% compared to 3.66% in
adults; the difference between these was not statistically significant (p=0.53).
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Ten patients with PTH required no further surgical intervention, whereas 31 required secondary surgical
control. These numbers reflect a 0.74% total non-surgical bleed rate and a 2.30% surgical bleed rate. The
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bleed rate prior to July 2015 was 3.15%, with 1.05% non-surgical bleeds and 2.10% of the patients
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requiring surgery. Post-July 2015, the bleed rate was 2.92%, with 0.44% non-surgical bleeds and 2.49%
requiring surgery. There were no statistically significant differences between the two groups with respect
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to overall, non-surgical, and surgical hemorrhage rates (p=0.81, 0.20, and 0.64 respectively). Of the total
bleeds, the need for secondary surgery in the narcotic group was 66.7% and 85% in the NSAID group. A
non-statistically significant difference exists in the percentage of PTH requiring surgical intervention
between the two cohorts (p=0.18). In addition to the 41 PTH patients who returned after in-house
tonsillectomies, 36 PTH patients seen at our institution had their initial tonsillectomy performed at outside
institutions. 19 of these patients (53%) required surgical intervention. As these patients received their
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initial surgery outside our institution, they were not included in the 1351 patients from which our
Discussion
The recent change in post-tonsillectomy pain management in children from narcotics to NSAIDs has led
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to debate over the efficacy and safety of this new regimen. Regarding tonsillectomy, otolaryngologists
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are primarily concerned with the potential of NSAIDs to cause increased intraoperative blood loss, more
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frequent postoperative hemorrhage and their associated complications, and an increased need for further
surgical intervention2. As NSAIDs inhibit platelet aggregation and can prolong bleeding time, their safety
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in tonsillectomy patients postoperatively has been controversial in large part due to the risk of PTH3.
However, an increased risk of postoperative bleeding and surgical intervention in the pediatric population
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has not been confirmed2. Our study of 1351 tonsillectomy patients sought to review the rates of PTH at a
quaternary medical center between the years 2013 and 2017, specifically addressing the impact of
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narcotic pain medications without NSAIDS, compared to NSAID postoperative pain management without
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Previous studies have similarly sought to evaluate the impact of NSAID use in post-tonsillectomy
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patients, with mixed results. A prospective, randomized, double-blinded study by Harley et al. in 1998
concluded that acetaminophen with codeine is more efficacious and safe than ibuprofen4. Their small
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study of 27 children demonstrated superior pain relief on postoperative days 1 and 3 with codeine, while
ibuprofen was associated with an increased rate of PTH and a longer need for medication for pain
control4. In 2015 D’Souza et al. performed a retrospective chart review to investigate the risk of post-
acetaminophen with narcotics3. The NSAID group demonstrated a higher rate of PTH occurring within 24
hours of surgery compared to the narcotic group, with 2% and 0.12% respectively (p<0.0001)3. The rate
of PTH occurring greater than 24 hours after surgery in the NSAID group was also higher at 3.8%
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compared to 1.1% in the narcotic group (p<0.001)3. Similarly, the NSAID group had a greater need for
additional surgical intervention, representing 1.6%; this was compared to 0.5% in the narcotic group (p =
0.01)3. Of note, although the ibuprofen group demonstrated an increased rate of PTH, the overall rate
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A 2014 retrospective medical record review by Mattos et al. also sought to compare the safety and
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efficacy of acetaminophen plus ibuprofen against that of opioids in children following tonsillectomy5. No
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statistically significant difference in the rate of postoperative hemorrhage was found when the group
prescribed ibuprofen and the no ibuprofen group were compared, with hemorrhage rages of 8.4% and
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8.2%, respectively5. No difference was found in the rate of surgical intervention between the two groups,
with 50% in the ibuprofen and 43.5% in the no ibuprofen group5. However, the five patients who
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presented with multiple bleeding episodes were all prescribed ibuprofen, suggesting a possible
increase in risk of PTH with the use of nonaspirin NSAIDs, although an increased risk associated with the
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Finally, a pair of meta-analyses performed in 2013 demonstrated no increased bleeding risk with
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NSAIDs. A Cochrane review by Lewis et al. involving 15 studies totaling 1101 pediatric patients found
non-significant increases in the risk of surgical and non-surgical PTH resulting from NSAID therapy7.
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The authors of that study concluded insufficient evidence exists to exclude an increased risk of PTH when
NSAIDs are used in the pediatric population. The second analysis by Riggin et al. involving 36 studies
comprising 1747 pediatric patients and 1446 adults found no increased risk of PTH, readmission, or
secondary operation in either population due to the use of NSAIDs over narcotics8.
Our sample of 1351 adult and pediatric patients found no statistically significant differences between the
use of narcotics versus NSAIDs and acetaminophen with respect to overall, non-surgical, and surgical
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hemorrhage rates. A non-significant increase in the likelihood of a patient with PTH requiring a second
operation for hemorrhage control was found; this increase may suggest that there is a higher risk of more
severe bleeding in patients receiving ibuprofen, which was similarly demonstrated in a recent
retrospective study performed by Mudd et al9. Despite this non-significant increase in the risk of
operative intervention, our data suggest that avoidance of narcotics, using only acetaminophen and
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ibuprofen, may represent a reasonable option for postoperative pain management. Of interest, our study
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found no statistically significant difference in the incidence rate of PTH in the pediatric (2.89%) versus
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adult (3.66%) population. While the literature is variable, recent studies have suggested that the risk of
PTH is higher in the adult population – this difference was not identified in our study10,11. Finally, our
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academic institution managed almost as many PTH patients who had their initial surgery outside our
institution as PTH patients from within our own institution, suggesting that academic and tertiary centers
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likely have a higher burden of PTH patients requiring management than other institutions.
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While our study indicates that NSAIDs offer a safe alternative to narcotics for children undergoing
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tonsillectomies, it has several important limitations. First, it was conducted retrospectively and did not
account for varying patient demographics. Patients were not controlled for gender, co-morbid conditions,
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or other surgical procedures performed at the time of tonsillectomy. Second, data was obtained from
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tonsillectomies performed by various surgeons within our department, allowing for potential differences
in surgical technique and skill that were not accounted for in the data analysis. Third, as the study was
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conducted retrospectively, patient adherence to the prescribed postoperative analgesic regimen could not
be assessed. Additionally, we did not control for any post-discharge changes to the medication regimen
Conclusion
requiring surgical intervention. This retrospective review found no increased bleeding risk associated
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References
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of Health and Human Services, Centers for Disease Control and Prevention; 2009.
3. D’Souza JN, Schmidt RJ, Xie L, Adelman JP, Nardone HC. Postoperative nonsteroidal anti-
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inflammatory drugs and risk of bleeding in pediatric intracapsular tonsillectomy. International Journal of
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Pediatric Otorhinolaryngology 2015;79(9):1472-1476.
4. Harley EH, Dattolo RA. Ibuprofen for tonsillectomy pain in children: efficacy and complications.
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Otolaryngology-Head and Neck Surgery 1998;119(5):492-496.
5. Mattos JL, Robison JG, Greenberg J, Yellon RF. Acetaminophen plus ibuprofen versus opioids for
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treatment of post-tonsillectomy pain in children. International Journal of Pediatric Otorhinolaryngology
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6. Krishna S, Hughes LF, Lin SY. Postoperative hemorrhage with nonsteroidal anti-inflammatory drug
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2003;129(10):1086-1089.
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7. Lewis SR, Nicholson A, Cardwell ME, Siviter G, Smith AF. Nonsteroidal anti-inflammatory drugs
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and perioperative bleeding in paediatric tonsillectomy. Cochrane Database of Systematic Reviews 2013;7.
doi: 10.1002/14651858.CD003591.pub3
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8. Riggin L, Ramakarishna J, Sommer DD, Koren G. A 2013 updated systematic review & meta-
analysis of 36 randomized controlled trials; no apparent effects of non steroidal anti-inflammatory agents
9. Mudd PA, Thottathil P, Giordano T, Wetmore RF, Elden L, Jawad AF, Ahumada L, Galvez JA.
Association between ibuprofen use and severity of surgically managed posttonsillectomy hemorrhage.
10. Shay S, Shapiro NL, Bhattacharyya N. Revisit rates and diagnoses following pediatric
11. Battacharyya N, Kepnes LJ. Revisits and postoperative hemorrhage after adult tonsillectomy. The
Laryngoscope 2014;124(7):1554-1556.
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Table 1. Comparison of Post-Tonsillectomy Hemorrhage Rates for Narcotic and NSAID Groups
Acetaminophen Acetaminophen
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Number of n = 667 n = 684 n = 1351 - -
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tonsillectomies Adults: 135 Adults: 111 Adults: 246
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Total PTH 21 (3.15%) 20 (2.92%) 41 (3.04%) 0.93 (0.51-1.70) 0.81
PTH
Note: Percentages in parentheses represent the rate of hemorrhage with respect to the number of
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