Nebulized Bupivacaine Analgesia for Cleft Palate Repair

Study Overview
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Brief Summary
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In this study we introduce a potent local anesthetic; bupivacaine 0.5% in two different doses by nebulization as a preemptive analgesia to compare efficacy and safety in children with cleft palate repair.

Detailed Description
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A written informed consent will be taken from the guardian of children. Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled study drug and 90 patients will be allocated in three groups (of 30 patients each) to receive; Nebulized Bupivacaine 0.50% 0.25 mg.kg-1 (Group B1) or Nebulized Bupivacaine 0.50% 0.50 mg.kg-1 (Group B2) or same volume of saline placebo (Group C).

Official Title
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Preemptive Nebulized Bupivacaine for Pain Control After Cleft Palate Repair in Children: A Randomized Double Blind Controlled Trial

Conditions
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Cleft Palate

Intervention / Treatment
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* Drug: Bupivacaine Hydrochloride
* Drug: Bupivacaine Hydrochloride
* Other: 0.9% saline


Participation Criteria
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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 . Exclusion Criteria: Coronary artery disease Hypertension Developmental delay Allergy to study drug

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group B1<br>Nebulized Bupivacaine 0.50% 0.25 mg.kg-1 | Drug: Bupivacaine Hydrochloride<br>* Preoperative Nebulized Bupivacaine 0.50% 0.25 mg.kg-1<br>* Other names: marcaine;|
| Experimental: Group B2<br>Nebulized Bupivacaine 0.50% 0.50 mg.kg-1 | Drug: Bupivacaine Hydrochloride<br>* Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1<br>* Other names: marcaine;|
| Placebo Comparator: Group C<br>Same volume of nebulized saline placebo | Other: 0.9% saline<br>* Preoperative nebulized same volume of saline placebo<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the 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 ≥3. 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, 2, 3, 4, 5, 6, 12 and 24 hour postoperative. | 24 hour after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, 2, 3, 4, 5, 6, 12 and 24 hour postoperative. | 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 ≥3. | 24 hour postoperative |