NCT05024825

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Albany Medical College · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2017-08-04
• Primary completion: 2021-05-19
• Completion: 2021-05-19
• First posted: 2021-08-27
• Last updated: 2021-08-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study