Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy
NCT ID: NCT05024825
Last Updated: 2021-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
17 participants
INTERVENTIONAL
2017-08-04
2021-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gabapentin
Patients in the gabapentin group will receive gabapentin preoperatively, one time dose of 10 mg/kg PO (maximum dose 600 mg) and will resume scheduled doses postoperatively of PO gabapentin, 300 mg PO every 8 hours, in addition to acetaminophen and ibuprofen for 7 days postoperative. Acetaminophen 15mg/kg PO (max 1 gm) every 4-6 hours as needed for pain, max dose 4 gm per day; Ibuprofen 4-10 mg/kg PO divided over 8 hours as needed for pain, max dose 40 mg/kg/day; gabapentin, 10 mg/kg standing every 8 hours (22).
Gabapentin
Patients in the gabapentin arm may at any point call the Pediatric ENT clinic if pain is not adequately controlled. Patients will be prescribed hydrocodone acetaminophen solution 7.5mg-325mg/15mL 5mL for ages 12-14 yrs and 10 mL for ages 15-18yrs, q 4-6 hours as needed for pain. Patients will be informed to stop taking gabapentin.
Hydrocodone
Patients in the hydrocodone group will receive scheduled doses of hydrocodone, acetaminophen and ibuprofen at scheduled doses. Acetaminophen 15mg/kg (max 1 gm) every 4-6 hours as needed for pain, max dose 4 gm per day; Ibuprofen 4-10 mg/kg PO divided over 8 hours as needed for pain, max dose 40 mg/kg/day; hydrocodone acetaminophen solution 7.5mg-325mg/15mL 5mL for ages 12-14yrs and 10 mL for ages 15-18yrs, q 4-6 hours as needed for pain.
hydrocodone, acetaminophen and ibuprofen
Patients in the hydrocodone group will receive scheduled doses of hydrocodone, acetaminophen and ibuprofen at scheduled doses. Acetaminophen 15mg/kg (max 1 gm) every 4-6 hours as needed for pain, max dose 4 gm per day; Ibuprofen 4-10 mg/kg PO divided over 8 hours as needed for pain, max dose 40 mg/kg/day; hydrocodone acetaminophen solution 7.5mg-325mg/15mL 5mL for ages 12-14yrs and 10 mL for ages 15-18yrs, q 4-6 hours as needed for pain.
Interventions
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Gabapentin
Patients in the gabapentin arm may at any point call the Pediatric ENT clinic if pain is not adequately controlled. Patients will be prescribed hydrocodone acetaminophen solution 7.5mg-325mg/15mL 5mL for ages 12-14 yrs and 10 mL for ages 15-18yrs, q 4-6 hours as needed for pain. Patients will be informed to stop taking gabapentin.
hydrocodone, acetaminophen and ibuprofen
Patients in the hydrocodone group will receive scheduled doses of hydrocodone, acetaminophen and ibuprofen at scheduled doses. Acetaminophen 15mg/kg (max 1 gm) every 4-6 hours as needed for pain, max dose 4 gm per day; Ibuprofen 4-10 mg/kg PO divided over 8 hours as needed for pain, max dose 40 mg/kg/day; hydrocodone acetaminophen solution 7.5mg-325mg/15mL 5mL for ages 12-14yrs and 10 mL for ages 15-18yrs, q 4-6 hours as needed for pain.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient scheduled for elective tonsillectomy +/- adenoidec-tomy, +/- BMTs.
* ASA physical status I and II.
Exclusion Criteria
* Patients who are actively on gabapentin or pregabalin, pre-existing with pain syndromes, chronic use of opioids, allergy to gabapentin, acetaminophen, and or NSAIDs
* Patient who lacks of fluency in English or inability to communicate pain.
* Patient who has severe asthma, bleeding disorders, and history of gastrointestinal bleeding, epilepsy, renal impairment or any other medical problem that in the opinion of the investigator would interfere with study population.
12 Years
18 Years
ALL
Yes
Sponsors
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Albany Medical College
OTHER
Responsible Party
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Farzana Afroze
Assistant Professor of Anesthesiology
Locations
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Albany Medical Center
Albany, New York, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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National Survey on Drug Use and Health: summary of national findings
National Vital Statistics System. Multiple cause of death file
Gabapentin Use in Postoperative and Neuropathic Pain in Children
Other Identifiers
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4891
Identifier Type: -
Identifier Source: org_study_id
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