Comparing dexmedetomidine and nalbuphine for preventing agitation after cleft palate surgery
Optic Nerve Sheath Diameter (ONSD): A New Modality to Assess Postoperative Agitation After a Single Bolus of Dexmedetomidine Versus Nalbuphine in Children With Cleft Palate Repair
This study tests whether a medication called dexmedetomidine works better than nalbuphine to help prevent agitation in young children after cleft palate surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 1 Year to 7 Years |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 2 sites (Assiut, Assuit and 1 other locations) |
| Trial ID | NCT04928391 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a single intravenous dose of dexmedetomidine compared to nalbuphine in preventing postoperative agitation in children undergoing cleft palate repair. A total of 90 children aged 1-7 years will be randomly assigned to receive either dexmedetomidine, nalbuphine, or a saline placebo at the end of their surgery. The study aims to determine which medication is more effective in managing agitation following anesthesia. Informed consent will be obtained from the guardians of the participants prior to enrollment.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1-7 years undergoing elective cleft palate repair with ASA physical status I-II.
Not a fit: Patients with conditions such as ventriculo-peritoneal shunt, suspected meningitis, or developmental delays may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of postoperative agitation in children, enhancing recovery and comfort after surgery.
How similar studies have performed: Other studies have shown varying success with similar approaches, but this specific comparison of dexmedetomidine and nalbuphine in this context is novel.
Eligibility criteria
Show full inclusion / exclusion 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: * Ventriculo-peritoneal shunt * Suspected meningitis * Congenital hydrocephalus * Clinical signs of suspected increased intracranial pressure * On treatment for seizures or metabolic diseases * Children with developmental delay * Hypersensitivity to dexmedetomidine or nalbuphine
Where this trial is running
Assiut, Assuit and 1 other locations
- Omar Soliman — Assiut, Assuit, Egypt (Recruiting)
- Assiut university hospital — Assiut, Egypt (Recruiting)
Study contacts
- Study coordinator: Omar Soliman, MD
- Email: omarmakram347@yahoo.com
- Phone: 01101266040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.