NCT03005483

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

December 13, 2016

Last Update Submit

December 28, 2016

Conditions

Pain, PostoperativeOrthopedic Disorder

Keywords

GABAPENTIN POSTOPERATIVE PAIN CHILD

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hour

Secondary Outcomes (1)

  • Reduce the opioid consumption through 24 hours postoperative observation

    24 hour

Study Arms (2)

Gabapentin

EXPERIMENTAL

Gabapentin 10 mg/kg in children submitted unilateral limb surgery

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

Placebo in children submitted unilateral limb surgery

Other: Placebo

Interventions

GabapentinDRUG

Orthopedic Surgery was applied for the treatment of osseous disorders

Also known as: Orthopedic Surgery
Gabapentin
PlaceboOTHER

Orthopedic Surgery was applied for the treatment of osseous disorders

Placebo

Eligibility Criteria

Age3 Months - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Infantil Albert Sabin

Fortaleza, Ceará, 60410794, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 20418301BACKGROUND

  • 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.

    PMID: 25230144BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeMusculoskeletal Diseases

Interventions

GabapentinOrthopedic Procedures

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and ProteinsTherapeuticsSurgical Procedures, Operative

Study Officials

  • Josenília Gomes, PhD

    Fortaleza University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Anesthesiologist

Study Record Dates

First Submitted

December 13, 2016

First Posted

December 29, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

May 1, 2016

Last Updated

December 29, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)