Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 .
Study Design
Arms and Interventions
| 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 Names:
|
| Placebo Comparator: Placebo Placebo in children submitted unilateral limb surgery |
Other: Placebo
Orthopedic Surgery was applied for the treatment of osseous disorders
|
Outcome Measures
Primary Outcome Measures
- Reduce the pain intensity using the Face Pain Scale [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
- Reduce the opioid consumption through 24 hours postoperative observation [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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Infantil Albert Sabin | Fortaleza | Ceara | Brazil | 60410794 |
Sponsors and Collaborators
- Hospital Infantil Albert Sabin
- Fortaleza University
Investigators
- Study Chair: Josenília Gomes, PhD, Fortaleza University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
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