Actively Recruiting

Phase 4
Age: 12Months - 48Months
All Genders
ID05821972

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

Age: 12Months - 48Months
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Post-operative Follow-up

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

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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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