Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery

Hospital Infantil Albert Sabin40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pain, Postoperative Orthopedic Disorder

Interventions

GabapentinDRUG

Orthopedic Surgery was applied for the treatment of osseous disorders

PlaceboOTHER

Orthopedic Surgery was applied for the treatment of osseous disorders

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Infantil Albert Sabin

Fortaleza, Ceará, Brazil

Outcomes

Primary Outcomes

Reduce the pain intensity using the Face Pain Scale

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.

Time frame: 24 hour

Secondary Outcomes

Reduce the opioid consumption through 24 hours postoperative observation

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.

Time frame: 24 hour

Data from ClinicalTrials.gov

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