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

PHASE4TerminatedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

August 4, 2017

Primary Completion Date

May 19, 2021

Study Completion Date

May 19, 2021

Conditions
Pain, Postoperative
Interventions
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.

Trial Locations (1)

12208

Albany Medical Center, Albany

Sponsors
All Listed Sponsors
lead

Albany Medical College

OTHER

NCT05024825 - Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy | Biotech Hunter | Biotech Hunter