In this study we introduce a potent local anesthetic; bupivacaine 0.5% in 0.5 mg/kg dose by nebulization as a preemptive analgesia to compare efficacy and safety in children with cleft palate repair.
A written informed consent will be taken from the guardian of children. Patients will be assigned randomly to two groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 60 patients will be allocated in two groups (of 30 patients each) to receive; Nebulized plain Bupivacaine 0.50% 0.50 mg.kg-1 (Group B) or same volume of saline placebo (Group C).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1
Preoperative nebulized same volume of saline placebo
Assiut university hospital
Asyut, Assuit, Egypt
RECRUITINGthe total postoperative consumption of rescue analgesics
Patients will receive IV paracetamol 15 mg.kg-1 as rescue analgesia if requested and if FLACC scores were ≥4. The FLACC (Face, Legs, Activity, Cry, Consolability). We rate the child in each of the five measurement categories, add together, and document total pain score (0 - 10) where 0= relaxed and no pain, 1-3= mild pain/discomfort, 4-6= moderate pain, 7-10= severe discomfort/pain. The scale will be recorded on admission to PACU (baseline), and at 30 minutes, 1, 3, 6, 12 and 24 hour postoperative.
Time frame: 24 hour after surgery
Postoperative FLACC score
The FLACC (Face, Legs, Activity, Cry, Consolability) is a behavioural pain assessment scale for use in non-verbal or pre-verbal patients unable to self-report their level of pain.We rate the child in each of the five measurement categories, add together, and document total pain score (0 - 10) where 0= relaxed and no pain, 1-3= mild pain/discomfort, 4-6= moderate pain, 7-10= severe discomfort/pain. The scale will be recorded on admission to PACU (baseline), and at 30 minutes, 1, 3, 6, 12 and 24 hour postoperative.
Time frame: 24 hour postoperative
The time to first request for rescue analgesics
Recording the first time when patients will receive IV paracetamol 15 mg.kg-1 as rescue analgesia if requested and if FLACC scores were ≥4.
Time frame: 24 hour postoperative
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