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Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery

H

Hospital Infantil Albert Sabin

Status and phase

Completed
Phase 4

Conditions

Orthopedic Disorder
Pain, Postoperative

Treatments

Drug: Gabapentin
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03005483
HOSPITALIAS

Details and patient eligibility

About

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.

Full 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 .

Enrollment

40 patients

Sex

All

Ages

3 months to 16 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups, including a placebo group

Gabapentin
Experimental group
Description:
Gabapentin 10 mg/kg in children submitted unilateral limb surgery
Treatment:
Drug: Gabapentin
Placebo
Placebo Comparator group
Description:
Placebo in children submitted unilateral limb surgery
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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