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Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery

NCT ID: NCT03005483

Last Updated: 2016-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-05-31

Brief Summary

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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

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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 .

Conditions

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Pain, Postoperative Orthopedic Disorder

Keywords

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GABAPENTIN POSTOPERATIVE PAIN CHILD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Gabapentin

Gabapentin 10 mg/kg in children submitted unilateral limb surgery

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Orthopedic Surgery was applied for the treatment of osseous disorders

Placebo

Placebo in children submitted unilateral limb surgery

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Orthopedic Surgery was applied for the treatment of osseous disorders

Interventions

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Gabapentin

Orthopedic Surgery was applied for the treatment of osseous disorders

Intervention Type DRUG

Placebo

Orthopedic Surgery was applied for the treatment of osseous disorders

Intervention Type OTHER

Other Intervention Names

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Orthopedic Surgery

Eligibility Criteria

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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.
Minimum Eligible Age

3 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fortaleza University

OTHER

Sponsor Role collaborator

Hospital Infantil Albert Sabin

OTHER

Sponsor Role lead

Responsible Party

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washington aspilicueta pinto filho

Medical Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Josenília Gomes, PhD

Role: STUDY_CHAIR

Fortaleza University

Locations

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Hospital Infantil Albert Sabin

Fortaleza, Ceará, Brazil

Site Status

Countries

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Brazil

References

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Rusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2.

Reference Type BACKGROUND
PMID: 20418301 (View on PubMed)

Mayell A, Srinivasan I, Campbell F, Peliowski A. Analgesic effects of gabapentin after scoliosis surgery in children: a randomized controlled trial. Paediatr Anaesth. 2014 Dec;24(12):1239-44. doi: 10.1111/pan.12524. Epub 2014 Sep 17.

Reference Type BACKGROUND
PMID: 25230144 (View on PubMed)

Other Identifiers

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HOSPITALIAS

Identifier Type: -

Identifier Source: org_study_id