Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12-48
SponsorAssiut University
About this trial
To compare the efficacy of the pre-operative nebulization of a combination of dexmedetomidine and ketamine versus nebulization of dexmedetomidine alone for sedation and prevention of emergence delirium in children undergoing cleft palate repair surgeries.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with American Society of Anesthesiologists (ASA) physical status I & II who will be scheduled for cleft palate repair surgeries
Disqualifiers
Parent refusal
Allergy to the study drugs
Suspected difficult airway
Patients with endocrine, renal, hepatic, and cardiac pathology
Trial design
Design model
Parallel
Treatments tested in this trial
Nebulization of dexmedetomidine and ketamine
DrugPre-operative nebulization of dexmedetomidine and ketamine
Nebulization of dexmedetomidine
DrugPre-operative nebulization of dexmedetomidine
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Nebulized dexmedetomidine and ketamineExperimental treatment 1 intervention
Group B: Nebulized dexmedetomidineActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
University of Michigan Sedation Scale (UMSS)
It ranges from 0 = awake, alert to 4 = unarousable
Time frame
Pre-operativeSecondary outcomes
1
Parental Separation using the Parenteral Separation Anxiety Scale (PSAS)
It ranges from 1 = easy separation to 4 = crying and clinging to parents. Higher score means a worse outcome.
Time frame
Pre-operative2
Watcha scale for emergence delirium
It ranges from 1= calm to 4 = agitated
Time frame
Postoperatively, up to 2 hours starting from arrival to the post-anesthesia care unit.Sponsors and contacts
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Source ClinicalTrials.gov