Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery

Phase 4

Completed

• Conditions: Orthopedic Disorder; Pain, Postoperative
• Interventions: Drug: Gabapentin; Other: Placebo

• Registration Number: NCT03005483
• Lead Sponsor: Hospital Infantil Albert Sabin

Brief Summary

This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral 10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in children from 3 months to 16 years submitted unilateral limb surgery.

Detailed Description

This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral 10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in children from 3 months to 16 years submitted unilateral limb surgery. The children were divided into 2 groups: the gabapentin group (GG) was administered gabapentin 1 to 2 hours before procedure (N-40) and the placebo group (GP) was administered placebo 1 to 2 hours before surgery (N-44). Both groups were subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%. All patients received dipyrone and rescue analgesic used was morphine into 2/2h. The variables studied were age, gender, weight, type of surgery, hemodynamics, postoperative pain and morphine consumption .

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-01
• Study Completion: 2016-05
• Status Verified: 2016-12
• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-28
• Last Update Submitted: 2016-12-28
• Study First Posted: 2016-12-29
• Last Update Posted: 2016-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Children between 3 months and 16 years who were previously healthy submitted to unilateral lower limb surgery

Exclusion Criteria

Children cardiac, pulmonary, renal and neurological diseases and allergy and refusal of parents, caregivers and patients to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gabapentin	Gabapentin	Gabapentin 10 mg/kg in children submitted unilateral limb surgery
Placebo	Placebo	Placebo in children submitted unilateral limb surgery

Primary Outcome Measures

Name	Time	Method
Reduce the pain intensity using the Face Pain Scale	24 hour	Subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%.The evaluation times were: 1 hour, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours after surgery. The time elapsed was recorded, from the end of the surgery to the first use of morphine. The parents and the patients themselves were instructed to request analgesic at any time.

Secondary Outcome Measures

Name	Time	Method
Reduce the opioid consumption through 24 hours postoperative observation	24 hour	Subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%. All patients received dipyrone and rescue analgesic used was administered morphine 50mcg / kg (maximum dose of 2mg) up to 2 / 2h when Face´s Scales reached 5 points.

Trial Locations

Locations (1)

Hospital Infantil Albert Sabin; 🇧🇷 Fortaleza, Ceara, Brazil