Post-Tonsillectomy Bleeding and Analgesic Use Before and After the FDA Boxed Warning Against Codeine.
FDA Boxed Warning
codeine
ibuprofen
post‐operative analgesics
post‐tonsillectomy bleeding
post‐tonsillectomy hemorrhage
tonsillectomy
Journal
The Laryngoscope
ISSN: 1531-4995
Titre abrégé: Laryngoscope
Pays: United States
ID NLM: 8607378
Informations de publication
Date de publication:
01 Jun 2024
01 Jun 2024
Historique:
revised:
05
05
2024
received:
14
02
2024
accepted:
08
05
2024
medline:
1
6
2024
pubmed:
1
6
2024
entrez:
1
6
2024
Statut:
aheadofprint
Résumé
The aim of this study was to investigate the trends in post-tonsillectomy analgesic utility and incidence of post-tonsillectomy hemorrhage before and after the 2013 FDA Boxed Warning against codeine use after pediatric tonsillectomy. A retrospective study was conducted using TriNetX. A search for patients up to 18 years from 2008 to 2022 within the US Collaborative Network identified 15,648,542 subjects. CPT and ICD-10 codes were used to identify children who experienced post-tonsillectomy hemorrhage within 14 days of a tonsillectomy. Analgesics given within 14 days of tonsillectomy were tabulated annually from 2008 to 2022, including codeine, ibuprofen, acetaminophen, oxycodone, ketorolac, and hydrocodone. Bleeding percentage and analgesic utility were grouped into events before and after 2013. Mean age at tonsillectomy was 5.6 years (SD = 3.0). Before 2013, the median percentage of children who experienced postoperative bleeding was 1.8% with 0.73% returning to the OR for bleeding control. After 2013, the median percentage of children who experienced postoperative bleeding was 2.4% (p = 0.029), and 0.99% returned to the OR (p = 0.008). Use of post-tonsillectomy codeine fell from 10.4% to 0.5% (p = 0.003) whereas ibuprofen rose from 2.0% to 63.9% (p = <0.001), acetaminophen from 42.8% to 77.2% (p = <0.001), ketorolac from 1.2% to 9.2% (p = <0.001), and oxycodone from 2.0% to 30.9% (p = <0.001). No change was detected in use of hydrocodone. Analgesics used post-tonsillectomy in children have changed since the FDA Boxed Warning against codeine. There has been a small but statistically significant increase in post-tonsillectomy bleeding. IV Laryngoscope, 2024.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024 The American Laryngological, Rhinological and Otological Society, Inc.
Références
Jaryszak EM, Lander L, Patel AK, Choi SS, Shah RK. Prolonged recovery after out‐patient pediatric adenotonsillectomy. Int J Pediatr Otorhinolaryngol. 2011;75(4):585‐588. https://doi.org/10.1016/j.ijporl.2011.01.
Baugh RF, Archer SM, Mitchell RB, et al. Clinical practice guideline: tonsillectomy in children. Otolaryngol Head Neck Surg. 2011;144(1 Suppl):S1‐S30. https://doi.org/10.1177/0194599810389949.
Isaacson G. Tonsillectomy healing. Ann Otol Rhinol Laryngol. 2012;121(10):645‐649. https://doi.org/10.1177/000348941212101004.
Hadden SM, Burke CN, Skotcher S, Voepel‐Lewis T. Early postoperative outcomes in children after adenotonsillectomy. J Perianesth Nurs. 2011;26(2):89‐95. https://doi.org/10.1016/j.jopan.2011.01.011.
Postier AC, Chambers C, Watson D, Schulz C, Friedrichsdorf SJ. A descriptive analysis of pediatric post‐tonsillectomy pain and recovery outcomes over a 10‐day recovery period from 2 randomized, controlled trials. Pain Rep. 2020;5(2):e819. https://doi.org/10.1097/PR9.0000000000000819.
Dhaduk N, Rodgers A, Govindan A, Kalyoussef E. Post‐tonsillectomy bleeding: a national perspective. Ann Otol Rhinol Laryngol. 2021;130(8):941‐947. https://doi.org/10.1177/0003489420987438.
Spektor Z, Saint‐Victor S, Kay DJ, Mandell DL. Risk factors for pediatric post‐tonsillectomy hemorrhage. Int J Pediatr Otorhinolaryngol. 2016;84:151‐155. https://doi.org/10.1016/j.ijporl.2016.03.005.
Handler SD, Miller L, Richmond KH, Baranak CC. Post‐tonsillectomy hemorrhage: incidence, prevention and management. Laryngoscope. 1986;96(11):1243‐1247. https://doi.org/10.1002/lary.1986.96.11.1243.
Goldman JL, Ziegler C, Burckardt EM. Otolaryngology practice patterns in pediatric tonsillectomy: the impact of the codeine boxed warning. Laryngoscope. 2018;128(1):264‐268. https://doi.org/10.1002/lary.26719.
Bhandari M, Bhandari A, Bhandari A. Recent updates on codeine. Pharm Methods. 2011;2(1):3‐8. https://doi.org/10.4103/2229-4708.81082.
St.Charles CS, Matt BH, Hamilton MM, Katz BP. A comparison of ibuprofen versus acetaminophen with codeine in the young tonsillectomy patient. Otolaryngol Head Neck Surg. 1997;117(1):76‐82.
Gasche Y, Daali Y, Fathi M, et al. Codeine intoxication associated with ultrarapid CYP2D6 metabolism. N Engl J Med. 2004;351(27):2827‐2831. https://doi.org/10.1056/NEJMoa041888.
Rawlinson E, Walker A, Skone R, Thillaivasan A, Bagshaw O. A randomised controlled trial of two analgesic techniques for paediatric tonsillectomy. Anaesthesia. 2011;66(10):919‐924. https://doi.org/10.1111/j.1365-2044.2011.06851.
Stokes W, Swanson RT, Schubart J, Carr MM. Postoperative bleeding associated with ibuprofen use after tonsillectomy: a meta‐analysis. Otolaryngol Head Neck Surg. 2019;161(5):734‐741. https://doi.org/10.1177/0194599819852328.
Mudd PA, Thottathil P, Giordano T, et al. Association between ibuprofen use and severity of surgically managed posttonsillectomy hemorrhage. JAMA Otolaryngol Head Neck Surg. 2017;143(7):712‐717. https://doi.org/10.1001/jamaoto.2016.3839.
Pfaff JA, Hsu K, Chennupati SK. The use of ibuprofen in posttonsillectomy analgesia and its effect on posttonsillectomy hemorrhage rate. Otolaryngol Head Neck Surg. 2016;155(3):508‐513. https://doi.org/10.1177/0194599816646363.
TriNetX – The World's Largest, Living Ecosystem of Real‐World Data and Evidence. TriNetX. 2023. https://trinetx.com/.
Edmonson MB, Zhao Q, Francis DO, et al. Association of patient characteristics with postoperative mortality in children undergoing tonsillectomy in 5 US states. JAMA. 2022;327(23):2317‐2325. https://doi.org/10.1001/jama.2022.8679.
Østvoll E, Sunnergren O, Ericsson E, et al. Mortality after tonsil surgery, a population study, covering eight years and 82,527 operations in Sweden. Eur Arch Otorhinolaryngol. 2015;272(3):737‐743. https://doi.org/10.1007/s00405-014-3312-z.
Windfuhr JP. Lethal post‐tonsillectomy hemorrhage. Auris Nasus Larynx. 2003;30(4):391‐396. https://doi.org/10.1016/j.anl.2003.07.004.
D'Souza JN, Schmidt RJ, Xie L, Adelman JP, Nardone HC. Postoperative nonsteroidal anti‐inflammatory drugs and risk of bleeding in pediatric intracapsular tonsillectomy. Int J Pediatr Otorhinolaryngol. 2015;79(9):1472‐1476. https://doi.org/10.1016/j.ijporl.2015.05.042.
Warltier DC, Marret E, Flahault A, Samama CM, Bonnet F. Effects of postoperative, nonsteroidal, antiinflammatory drugs on bleeding risk after tonsillectomy: meta‐analysis of randomized, controlled trials. Anesthesiology. 2003;98(6):1497‐1502. https://doi.org/10.1097/00000542-200306000-00030.
Diercks GR, Comins J, Bennett K, et al. Comparison of ibuprofen vs acetaminophen and severe bleeding risk after pediatric tonsillectomy: a noninferiority randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2019;145(6):494‐500. https://doi.org/10.1001/jamaoto.2019.0269.
Cardwell M, Siviter G, Smith A. Non‐steroidal anti‐inflammatory drugs and perioperative bleeding in paediatric tonsillectomy. Cochrane Database Syst Rev. 2005;2:CD003591. https://doi.org/10.1002/14651858.CD003591.pub2.
Fonseca ACG, Engelhardt MI, Huang ZJ, Jiang ZY, Yuksel S, Roy S. Effect of changing postoperative pain management on bleeding rates in tonsillectomy patients. Am J Otolaryngol. 2018;39(4):445‐447. https://doi.org/10.1016/j.amjoto.2018.03.028.
Riggin L, Ramakrishna 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 on the risk of bleeding after tonsillectomy. Clin Otolaryngol. 2013;38(2):115‐129. https://doi.org/10.1111/coa.12106.
De Ravin E, Banik GL, Buzi A. Effect of ibuprofen on severity of surgically‐managed pediatric post‐tonsillectomy hemorrhage. Int J Pediatr Otorhinolaryngol. 2023;164:111422. https://doi.org/10.1016/j.ijporl.2022.111422.
Harounian JA, Schaefer E, Schubart J, Carr MM. Pediatric Posttonsillectomy hemorrhage: demographic and geographic variation in health care costs in the United States. Otolaryngol Head Neck Surg. 2016;155(2):289‐294. https://doi.org/10.1177/0194599816641627.
Keren R, Luan X, Localio R, et al. Prioritization of comparative effectiveness research topics in hospital pediatrics. Arch Pediatr Adolesc Med. 2012;166(12):1155‐1164. https://doi.org/10.1001/archpediatrics.2012.1266.
Curtis JL, Harvey DB, Willie S, et al. Causes and costs for ED visits after pediatric adenotonsillectomy. Otolaryngol Head Neck Surg. 2015;152(4):691‐696. https://doi.org/10.1177/0194599815572123.
Lee YC, Hsin LJ, Lin WN, Fang TJ, Tsai YT, Luo CM. Adolescents and adults undergoing temperature‐controlled surgical instruments vs electrocautery in tonsillectomy: a systematic review and meta‐analysis of randomized clinical trials. JAMA Otolaryngol Head Neck Surg. 2020;146(4):339‐346. https://doi.org/10.1001/jamaoto.2019.4605.
Gonçalves AI, Rato C, de Vilhena D, Duarte D, Lopes G, Trigueiros N. Evaluation of post‐tonsillectomy hemorrhage and assessment of risk factors. Eur Arch Otorhinolaryngol. 2020;277(11):3095‐3102. https://doi.org/10.1007/s00405-020-06060-1.
Russo E, Festa BM, Costantino A, Bernardocchi A, Spriano G, De Virgilio A. Postoperative morbidity of different tonsillectomy techniques: a systematic review and network meta‐analysis. Laryngoscope. 2023;134:1696‐1704.
Leader BA, Wiebracht ND, Meinzen‐Derr J, Ishman SL. The impact of resident involvement on tonsillectomy outcomes and surgical time. Laryngoscope. 2020;130(10):2481‐2486. https://doi.org/10.1002/lary.28427.
Gallagher TQ, Wilcox L, McGuire E, Derkay CS. Analyzing factors associated with major complications after adenotonsillectomy in 4776 patients: comparing three tonsillectomy techniques. Otolaryngol Head Neck Surg. 2010;142(6):886‐892. https://doi.org/10.1016/j.otohns.2010.02.019.
Perkins JN, Liang C, Gao D, Shultz L, Friedman NR. Risk of post‐tonsillectomy hemorrhage by clinical diagnosis. Laryngoscope. 2012;122(10):2311‐2315. https://doi.org/10.1002/lary.23421.
Patel HH, Straight CE, Lehman EB, Tanner M, Carr MM. Indications for tonsillectomy: a 10 year retrospective review. Int J Pediatr Otorhinolaryngol. 2014;78(12):2151‐2155.
Ahmed AO, Aliyu I, Kolo ES. Indications for tonsillectomy and adenoidectomy: our experience. Niger J Clin Pract. 2014;17(1):90‐94.
Kubba H, Downie LS. Trends in tonsillectomy surgery in children in Scotland 2000–2018. Clin Otolaryngol. 2021;46(1):146‐153.
Miller CH, Soucie JM, Byams VR, et al. Occurrence rates of inherited bleeding disorders other than haemophilia and von Willebrand disease among people receiving care in specialized treatment centers in the United States. Haemophilia. 2022;28(3):e75‐e78.
Mitchell RB, Archer SM, Ishman SL, et al. Clinical practice guideline: tonsillectomy in children (update)‐executive summary. Otolaryngol Head Neck Surg. 2019;160(2):187‐205.