Nebulized Bupivacaine Analgesia for Cleft Palate Repair

Assiut University

Status and phase: Enrolling; Phase 3

Conditions: Cleft Palate

Treatments: Other: 0.9% saline; Drug: Bupivacaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04928352

17300615

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children (age 1-7 years) of American Society of Anaesthesiologists physical status (ASA) I-II
• Elective cleft palate repair ± cleft lip surgery under general anesthesia .

Exclusion criteria

• Coronary artery disease
• Hypertension
• Developmental delay
• Allergy to study drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Group B

Experimental group

Description:

Nebulized Bupivacaine 0.50% 0.50 mg.kg-1

Treatment:

Drug: Bupivacaine Hydrochloride

Group C

Placebo Comparator group

Description:

Same volume of nebulized saline placebo

Treatment:

Other: 0.9% saline