Ketofol Versus Dexmedetomidine for Prevention of Emergence Delirium in Pediatric Patients Undergoing Squint Surgeries

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age2-6
SponsorCairo University

About this trial

The aim of the study is to compare the effectiveness of ketofol for the prevention of emergence delirium in pediatric patients undergoing squint surgery, in comparison to dexmedetomidine.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

• All pediatric patients aged 2 to 6 years.

Both sexes.

ASA physical status I and II.

Patients undergoing squint surgery.

Disqualifiers

• Refusal of parents.

Patient sensitivity to any of the study medications.

Known neurological disease that can affect the assessment of ED postoperatively.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ketamine

    Drug

    continous infusion during surgery

  • Dexmedetomidine

    Drug

    continous infusion during surgery

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Ketofol GroupExperimental treatment 1 intervention
Group B: DexmedetomidineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of postoperative ED using PAED scale at time of admission to PACU in both groups.

During their stay at PACU, delirium will be assessed at 5, 10, 15, 20, 25, and 30 minutes following extubation via the Pediatric Anesthesia Emergence Delirium scale (PAED) . ED will be established when the child have a score of 10 or more. If the child has a score of 10 or more, rescue sedation will be done via propofol 1 mg/kg .

Time frame
PAED score immediately after admission to PACU .

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.