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Nebulized Bupivacaine Analgesia for Cleft Palate Repair

ConditionCleft Palate
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-7
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 .

Disqualifiers

Coronary artery disease

Hypertension

Developmental delay

Allergy to study drug

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivacaine Hydrochloride

    Drug

    Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1

  • 0.9% saline

    Other intervention

    Preoperative nebulized same volume of saline placebo

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group BExperimental treatment 1 intervention
Group B: Group CPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 ≥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

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov
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