Comparing Nebulized Dexmedetomidine With and Without Ketamine for Sedation and Reducing Delirium in Children Having Cleft Palate Repair

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.

Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate