Actively Recruiting
Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine to Induce Preoperative Sedation and Attenuate Emergence Agitation in Children Undergoing Cleft Palate Repair Surgeries
Led by Assiut University · Updated on 2025-10-03
60
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of two pre-operative sedation methods in children undergoing cleft palate repair surgeries. It focuses on assessing sedation and the prevention of emergence delirium, which is a state of confusion and agitation following anesthesia. The study addresses the distress children experience before surgery and evaluates drugs that may help improve their experience and recovery during this critical period. Participants will receive one of two treatments before surgery: a nebulized combination of dexmedetomidine and ketamine or nebulized dexmedetomidine alone. Dexmedetomidine is a selective alpha-2 adrenergic agonist used for pediatric sedation, while ketamine may help reduce some side effects of dexmedetomidine and speed up sedation onset without affecting breathing. These treatments are given via nebulization just before surgery. During the study, researchers will monitor sedation levels using the University of Michigan Sedation Scale before surgery. They will also assess parental separation anxiety and observe emergence delirium using specific scales after surgery. The monitoring period for emergence delirium lasts up to two hours after arrival in the recovery unit. The study is randomized and blinded, with careful observation of outcomes to determine the best sedation approach for young children undergoing cleft palate repair.
CONDITIONS
Brief Title
Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with American Society of Anesthesiologists (ASA) physical status I & II
- Scheduled for cleft palate repair surgeries
- Age between 12 and 48 months
You will not qualify if you...
- Parent refusal
- Allergy to the study drugs (dexmedetomidine or ketamine)
- Suspected difficult airway
- Endocrine, renal, hepatic, or cardiac pathology
- Psychiatric diseases
- Asthma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Short period before surgery
Participants receive pre-operative nebulization of either dexmedetomidine combined with ketamine or dexmedetomidine alone before cleft palate repair surgery.
1 pre-operative visit (in-person)
Duration - Up to 2 hours after surgery
Participants are monitored for emergence agitation and recovery in the post-anesthesia care unit.
1 post-operative visit (in-person)
Trial Site Locations
Total: 1 location
1
Assiut University
Asyut, Egypt, 71515
Actively Recruiting
Research Team
F
Fatma N. Mohamed, M.D.
S
Samar Ah. Abdellah, M.B.B.Ch.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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