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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B | Experimental | Nebulized Bupivacaine 0.50% 0.50 mg.kg-1 |
|
| Group C | Placebo Comparator | Same volume of nebulized saline placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Hydrochloride | Drug | Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1 |
|
| 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 ≥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. | 24 hour after surgery |
| 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, 3, 6, 12 and 24 hour postoperative. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Omar Soliman, MD | Contact | 01101266040 | omarmakram347@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Omar Soliman, MD | Assiut University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university hospital | Recruiting | Asyut | Assuit | Assuit universi | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24525630 | Result | 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. |
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| ID | Term |
|---|---|
| D002972 | Cleft Palate |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| 0.9% saline | Other | Preoperative nebulized same volume of saline placebo |
|
|
| 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. | 24 hour postoperative |
| D019465 |
| Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D009059 | Mouth Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |