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

Phase 4TerminatedNCT05024825

Albany Medical College17 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain, Postoperative

Interventions

GabapentinDRUG

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 ibuprofenDRUG

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.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Albany Medical Center

Albany, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Through completion of the study. Time frame per subject is 7 days.

Secondary Outcomes

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.

Time frame: Through completion of the study. Time frame per subject is 7 days.

Medication Adverse Effect

Patient reported adverse effect to medications given

Time frame: Through completion of the study. Time frame per subject is 7 days.

Data from ClinicalTrials.gov

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