Back to resultsGabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery
Primary Purpose
Pain, Postoperative, Orthopedic Disorder
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring GABAPENTIN POSTOPERATIVE PAIN CHILD
Eligibility 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.
Sites / Locations
- Hospital Infantil Albert Sabin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gabapentin
Placebo
Arm Description
Gabapentin 10 mg/kg in children submitted unilateral limb surgery
Placebo in children submitted unilateral limb surgery
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03005483
First Posted
December 13, 2016
Last Updated
December 28, 2016
Sponsor
Hospital Infantil Albert Sabin
Collaborators
Fortaleza University
1. Study Identification
Unique Protocol Identification Number
NCT03005483
Brief Title
Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery
Official Title
Placebo Controlled, Randomized,Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Infantil Albert Sabin
Collaborators
Fortaleza University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Orthopedic Disorder
Keywords
GABAPENTIN POSTOPERATIVE PAIN CHILD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
Gabapentin 10 mg/kg in children submitted unilateral limb surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo in children submitted unilateral limb surgery
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Orthopedic Surgery
Intervention Description
Orthopedic Surgery was applied for the treatment of osseous disorders
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Orthopedic Surgery was applied for the treatment of osseous disorders
Primary Outcome Measure Information:
Title
Reduce the pain intensity using the Face Pain Scale
Description
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 Outcome Measure Information:
Title
Reduce the opioid consumption through 24 hours postoperative observation
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josenília Gomes, PhD
Organizational Affiliation
Fortaleza University
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Infantil Albert Sabin
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60410794
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20418301
Citation
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.
Results Reference
background
PubMed Identifier
25230144
Citation
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.
Results Reference
background
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Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery
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