Orthopedic Disorder, Pain, Postoperative
Conditions
Keywords
GABAPENTIN POSTOPERATIVE PAIN CHILD
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 .
Interventions
DRUGGabapentin
Orthopedic Surgery was applied for the treatment of osseous disorders
OTHERPlacebo
Orthopedic Surgery was applied for the treatment of osseous disorders
Sponsors
Fortaleza University
Hospital Infantil Albert Sabin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 16 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Outcome results
None listed