Nebulized Bupivacaine Analgesia for Cleft Palate Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-14

Study Completion Date

2026-09-20

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Cleft Palate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group B

Nebulized Bupivacaine 0.50% 0.50 mg.kg-1

Group Type EXPERIMENTAL

Bupivacaine Hydrochloride

Intervention Type DRUG

Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1

Group C

Same volume of nebulized saline placebo

Group Type PLACEBO_COMPARATOR

0.9% saline

Intervention Type OTHER

Preoperative nebulized same volume of saline placebo

Interventions

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Bupivacaine Hydrochloride

Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1

Intervention Type DRUG

0.9% saline

Preoperative nebulized same volume of saline placebo

Intervention Type OTHER

Other Intervention Names

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marcaine Normal saline

Eligibility Criteria

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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 .