Dexmedetomidine-Midazolam vs. Ketamine-Midazolam on Emergence Delirium
ConditionEmergence Delirium
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-6
SponsorKasr El Aini Hospital
About this trial
Fifty children undergoing heart catheterization without local anesthesia in the skin will be randomly divided into two groups.
Group DM (Dexmedetomidine + Midazolam) and Group KM (Ketamine + Midazolam)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for elective cardiac catheterization under general anesthesia.
Disqualifiers
neurological disorder, psychiatric disease, or current psychoactive medication.
allergy.
significant systemic comorbidities.
Trial design
Design model
Parallel
Treatments tested in this trial
Dexmedetomidine and Midazolam
DrugChildren will receive Dexamedetomedine and Midazolam
Ketamine and Midazolam
DrugChildren will receive Ketamine and Midazolam
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Dexmedetomidine-MidazolamActive comparator 1 intervention
Group B: ketamine-MidazolamActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Emergence delirium
Incidence of emergence delirium assessed using the Pediatric Anesthesia Emergence Delirium PAED scale. The scale consists of five behavioral items, each rated on a 5-point scale from 0 to 4(Eye contact, Purposefulness, Awareness, Restlessness, Inconsolability),Total scores range from 0 to 20.A PAED score ≥10 will be considered a clinically significant ED.
Time frame
30 minutes post-anesthesiaSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov