Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy

Pain, Postoperative Clinical Trial

Official title:

Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05024825
• Other study ID #: 4891
• Status: Terminated
• Phase: Phase 4
• Start date: August 4, 2017
• Est. completion date: May 19, 2021

Study information

• Verified date: August 2021
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, randomized, non-blinded control trial designed to determine if administration of gabapentin postoperatively is effective in reducing and possibly eliminating the use of opioid analgesics following tonsillectomies in the adolescent population.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: May 19, 2021
• Est. primary completion date: May 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Patients aged 12-18.
• Patient scheduled for elective tonsillectomy +/- adenoidec-tomy, +/- BMTs.
• ASA physical status I and II.

Exclusion Criteria:

• Severe upper respiratory tract infections.
• 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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Harley EH, Dattolo RA. Ibuprofen for tonsillectomy pain in children: efficacy and complications. Otolaryngol Head Neck Surg. 1998 Nov;119(5):492-6. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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). pii: e20162387. doi: 10.1542/peds.2016-2387. Epub 2017 Mar 20. — View Citation

Mikkelsen S, Hilsted KL, Andersen PJ, Hjortsø NC, Enggaard TP, Jørgensen 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2016 Jul 26. Review. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total opioid equivalent dose	The primary outcome variable will be the total opioid equivalent dose recorded over two weeks. The proposed study will test the null hypothesis that the two population (gabapentin and placebo) means are equal. The criterion for significance (alpha) has been set at 0.050. The test is 2-tailed, which means that an effect in either direction will be interpreted.	Through completion of the study. Time frame per subject is 7 days.
Secondary	Post operative pain score determined by Visual Analog Survey Scale	Pain severity, The pain VAS is a unidimensional measure of pain intensity. Scale ranges from 1-10. Score of 0 indicates no pain. Score of 1-3 indicates mild pain, score of 4-6 indicates moderate pain, score of 6 is severe pain, score of 7-9 is very severe pain, and a score of 10 is worst pain possible.	Through completion of the study. Time frame per subject is 7 days.
Secondary	Medication Adverse Effect	Patient reported adverse effect to medications given	Through completion of the study. Time frame per subject is 7 days.

External Links

•   Gabapentin Use in Postoperative and Neuropathic Pain in Children
•   National Survey on Drug Use and Health: summary of national findings
•   National Vital Statistics System. Multiple cause of death file