drugset / Trial / NCT05024825
Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to determine if administration of gabapentin preoperatively followed by a standing postoperative course is effective in reducing and possibly eliminating the use of opioid analgesics following this procedure. As a secondary outcome, it will evaluate the possible improvement in post tonsillectomy pain control with the use of a standing dose of gabapentin.
Timeline
- Start
- 2017-08-04
- Primary completion
- 2021-05-19
- Completion
- 2021-05-19
Publications
- Background Fortuna RJ, Robbins BW, Caiola E, Joynt M, Halterman JS. Prescribing of controlled medications to adolescents and young adults in the United States. Pediatrics. 2010 Dec;126(6):1108-16. doi: 10.1542/peds.2010-0791. Epub 2010 Nov 29.
- Background McCabe SE, West BT, Veliz P, McCabe VV, Stoddard SA, Boyd CJ. Trends in Medical and Nonmedical Use of Prescription Opioids Among US Adolescents: 1976-2015. Pediatrics. 2017 Apr;139(4):e20162387. doi: 10.1542/peds.2016-2387. Epub 2017 Mar 20.
- Background Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol Head Neck Surg. 2019 Feb;160(1_suppl):S1-S42. doi: 10.1177/0194599818801757.
- Background Crandall M, Lammers C, Senders C, Braun JV. Children's tonsillectomy experiences: influencing factors. J Child Health Care. 2009 Dec;13(4):308-21. doi: 10.1177/1367493509344821. Epub 2009 Oct 15.
- Background Harley EH, Dattolo RA. Ibuprofen for tonsillectomy pain in children: efficacy and complications. Otolaryngol Head Neck Surg. 1998 Nov;119(5):492-6. doi: 10.1016/S0194-5998(98)70107-X.
- Background Bedwell JR, Pierce M, Levy M, Shah RK. Ibuprofen with acetaminophen for postoperative pain control following tonsillectomy does not increase emergency department utilization. Otolaryngol Head Neck Surg. 2014 Dec;151(6):963-6. doi: 10.1177/0194599814549732. Epub 2014 Sep 9.
- Background Hong SM, Cho JG, Chae SW, Lee HM, Woo JS. Coblation vs. Electrocautery Tonsillectomy: A Prospective Randomized Study Comparing Clinical Outcomes in Adolescents and Adults. Clin Exp Otorhinolaryngol. 2013 Jun;6(2):90-3. doi: 10.3342/ceo.2013.6.2.90. Epub 2013 Jun 14.
- Background Haig GM, Bockbrader HN, Wesche DL, Boellner SW, Ouellet D, Brown RR, Randinitis EJ, Posvar EL. Single-dose gabapentin pharmacokinetics and safety in healthy infants and children. J Clin Pharmacol. 2001 May;41(5):507-14. doi: 10.1177/00912700122010384.
- Background Sanders JG, Dawes PJ. Gabapentin for Perioperative Analgesia in Otorhinolaryngology-Head and Neck Surgery: Systematic Review. Otolaryngol Head Neck Surg. 2016 Dec;155(6):893-903. doi: 10.1177/0194599816659042. Epub 2016 Jul 26.
- Background Hwang SH, Park IJ, Cho YJ, Jeong YM, Kang JM. The efficacy of gabapentin/pregabalin in improving pain after tonsillectomy: A meta-analysis. Laryngoscope. 2016 Feb;126(2):357-66. doi: 10.1002/lary.25636. Epub 2015 Sep 25.
- Background Amani S, Abedinzadeh MR. Effects of Oral Gabapentin, Local Bupivacaine and Intravenous Pethidine on Post Tonsillectomy Pain. Iran J Otorhinolaryngol. 2015 Sep;27(82):343-8.
- Background Retraction: Evaluation of gabapentin and dexamethasone alone or in combination for pain control after adenotonsillectomy in children. Saudi J Anaesth. 2018 Oct-Dec;12(4):662. doi: 10.4103/1658-354X.241421.
- Background Yeganeh Mogadam A, Fazel MR, Parviz S. Comparison of analgesic effect between gabapentin and diclofenac on post-operative pain in patients undergoing tonsillectomy. Arch Trauma Res. 2012 Fall;1(3):108-11. doi: 10.5812/atr.7931. Epub 2012 Oct 14.
- Background Amin SM, Amr YM. Comparison between preemptive gabapentin and paracetamol for pain control after adenotonsillectomy in children. Anesth Essays Res. 2011 Jul-Dec;5(2):167-70. doi: 10.4103/0259-1162.94758.
- Background Moore A. Gabapentin and post tonsillectomy pain-the next best thing? Arch Trauma Res. 2013 Winter;1(4):188-90. doi: 10.5812/atr.9938. Epub 2013 Feb 1. No abstract available.
- Background Jeon EJ, Park YS, Park SS, Lee SK, Kim DH. The effectiveness of gabapentin on post-tonsillectomy pain control. Eur Arch Otorhinolaryngol. 2009 Oct;266(10):1605-9. doi: 10.1007/s00405-008-0897-0. Epub 2008 Dec 20.
- Background Mikkelsen S, Hilsted KL, Andersen PJ, Hjortso NC, Enggaard TP, Jorgensen DG, Hansen M, Henriksen J, Dahl JB. The effect of gabapentin on post-operative pain following tonsillectomy in adults. Acta Anaesthesiol Scand. 2006 Aug;50(7):809-15. doi: 10.1111/j.1399-6576.2006.01057.x.
- Background Pande AC, Pollack MH, Crockatt J, Greiner M, Chouinard G, Lydiard RB, Taylor CB, Dager SR, Shiovitz T. Placebo-controlled study of gabapentin treatment of panic disorder. J Clin Psychopharmacol. 2000 Aug;20(4):467-71. doi: 10.1097/00004714-200008000-00011.
- Background Tiippana EM, Hamunen K, Kontinen VK, Kalso E. Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety. Anesth Analg. 2007 Jun;104(6):1545-56, table of contents. doi: 10.1213/01.ane.0000261517.27532.80.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gabapentin | Small molecule | 300 mg | Oral |
| Comparator | Hydrocodone | Unknown | 7.5 mg | — |
| Comparator | Acetaminophen | Small molecule | 15 mg/kg | Oral |
| Comparator | Ibuprofen | Small molecule | 4 mg/kg | Oral |
| Comparator | Ibuprofen | Small molecule | 10 mg/kg | Oral |
Indications
No indication recorded.