Cleft PalatePhase 3NCT04928352
Nebulized Bupivacaine Analgesia for Cleft Palate Repair
A Phase 3 study testing Bupivacaine Hydrochloride and 0.9% saline in people with Cleft Palate, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Cleft Palate
- What is being tested?
- Bupivacaine Hydrochloride and 0.9% saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jun 2021to 20 Nov 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 .
Who cannot join
- Coronary artery disease
- Hypertension
- Developmental delay
- Allergy to study drug
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university hospital
Asyut, Assuit, Assuit universi
Omar Soliman, 01101266040, omarmakram347@yahoo.com
About this study
Official title: Preemptive Nebulized Bupivacaine for Pain Control After Cleft Palate Repair in Children: A Randomized Double Blind Controlled 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.
Read the detailed 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).
- Conditions
- Cleft Palate
- Being tested
- Bupivacaine Hydrochloride, 0.9% saline
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HydrochlorideDrug
Also called marcaine
Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1
0.9% salineOther
Also called Normal saline
Preoperative nebulized same volume of saline placebo
| Study group | Role | What they receive |
|---|---|---|
| Group B | Experimental | Nebulized Bupivacaine 0.50% 0.50 mg.kg-1 Receives: Drug: Bupivacaine Hydrochloride |
| Group C | Placebo comparator | Same volume of nebulized saline placebo Receives: Other: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hour after surgery
Secondary outcomes (2)
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.
Measured: 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 ≥4.
Measured: 24 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start14 Jun 2021
- Primary completion10 Nov 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Makram Soliman, Assiut University
- Investigators
- Omar Soliman, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928352
- Sponsor's protocol ID
- 17300615
- Status last verified
- Sep 2026
- First submitted
- 10 Jun 2021
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24525630