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Nebulized Bupivacaine Analgesia for Cleft Palate Repair

Primary Purpose

Cleft Palate

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride
Bupivacaine Hydrochloride
0.9% saline
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Palate

Eligibility Criteria

1 Year - 7 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Assiut university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Group B1

Group B2

Group C

Arm Description

Nebulized Bupivacaine 0.50% 0.25 mg.kg-1

Nebulized Bupivacaine 0.50% 0.50 mg.kg-1

Same volume of nebulized saline placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 10, 2021
Last Updated
April 11, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04928352
Brief Title
Nebulized Bupivacaine Analgesia for Cleft Palate Repair
Official Title
Preemptive Nebulized Bupivacaine for Pain Control After Cleft Palate Repair in Children: A Randomized Double Blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
June 10, 2024 (Anticipated)
Study Completion Date
June 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group B1
Arm Type
Experimental
Arm Description
Nebulized Bupivacaine 0.50% 0.25 mg.kg-1
Arm Title
Group B2
Arm Type
Experimental
Arm Description
Nebulized Bupivacaine 0.50% 0.50 mg.kg-1
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Same volume of nebulized saline placebo
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Other Intervention Name(s)
marcaine
Intervention Description
Preoperative Nebulized Bupivacaine 0.50% 0.25 mg.kg-1
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Other Intervention Name(s)
marcaine
Intervention Description
Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1
Intervention Type
Other
Intervention Name(s)
0.9% saline
Other Intervention Name(s)
Normal saline
Intervention Description
Preoperative nebulized same volume of saline placebo
Primary Outcome Measure Information:
Title
the total postoperative consumption of rescue analgesics
Description
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.
Time Frame
24 hour after surgery
Secondary Outcome Measure Information:
Title
Postoperative FLACC score
Description
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.
Time Frame
24 hour postoperative
Title
The time to first request for rescue analgesics
Description
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.
Time Frame
24 hour postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar Soliman, MD
Phone
01101266040
Email
omarmakram347@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Soliman, MD
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut university hospital
City
Assiut
State/Province
Assuit
ZIP/Postal Code
Assuit universi
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar Soliman
Phone
01101266040
Email
omarmakram347@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24525630
Citation
Chiono J, Raux O, Bringuier S, Sola C, Bigorre M, Capdevila X, Dadure C. Bilateral suprazygomatic maxillary nerve block for cleft palate repair in children: a prospective, randomized, double-blind study versus placebo. Anesthesiology. 2014 Jun;120(6):1362-9. doi: 10.1097/ALN.0000000000000171.
Results Reference
result

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Nebulized Bupivacaine Analgesia for Cleft Palate Repair

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