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Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery

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ClinicalTrials.gov Identifier: NCT03005483
Recruitment Status : Completed
First Posted : December 29, 2016
Last Update Posted : December 29, 2016
Sponsor:
Collaborator:
Fortaleza University
Information provided by (Responsible Party):
washington aspilicueta pinto filho, 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Orthopedic Disorder Drug: Gabapentin Other: Placebo Phase 4

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo Controlled, Randomized,Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery
Study Start Date : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gabapentin
Gabapentin 10 mg/kg in children submitted unilateral limb surgery
Drug: Gabapentin
Orthopedic Surgery was applied for the treatment of osseous disorders
Other Name: Orthopedic Surgery

Placebo Comparator: Placebo
Placebo in children submitted unilateral limb surgery
Other: Placebo
Orthopedic Surgery was applied for the treatment of osseous disorders




Primary Outcome Measures :
  1. Reduce the pain intensity using the Face Pain Scale [ Time Frame: 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 :
  1. Reduce the opioid consumption through 24 hours postoperative observation [ Time Frame: 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.



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Ages Eligible for Study:   3 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03005483


Locations
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Brazil
Hospital Infantil Albert Sabin
Fortaleza, Ceara, Brazil, 60410794
Sponsors and Collaborators
Hospital Infantil Albert Sabin
Fortaleza University
Investigators
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Study Chair: Josenília Gomes, PhD Fortaleza University
Publications:
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Responsible Party: washington aspilicueta pinto filho, Medical Anesthesiologist, Hospital Infantil Albert Sabin
ClinicalTrials.gov Identifier: NCT03005483    
Other Study ID Numbers: HOSPITALIAS
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by washington aspilicueta pinto filho, Hospital Infantil Albert Sabin:
GABAPENTIN POSTOPERATIVE PAIN CHILD
Additional relevant MeSH terms:
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Musculoskeletal Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents