Comparison between oral dexmedetomidine and oral midazolam as premedicant in children undergoing herniotomy
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Level of sedation, parental separation anxiety, IV acceptability
Study Overview
Brief Summary
Background and Aims: Midazolam has been the most popular premedicant in children despite its side effects. Dexmedetomidine with its favourable clinical profile is a suitable alternative, but with limited research. The aim of this study was to compare the effectiveness of dexmedetomidine and midazolam as oral premedicants in children
Materials and methods: 80 children of ASA PS I scheduled for elective herniotomy were included in this prospective randomized observational study. Patients were randomly assigned to receive either dexmedetomidine 4microgram/ kg or midazolam 0.5mg/kg orally 40min prior to induction. Preoperative sedation, response to parental separation and venepuncture, emergence agitation, recovery nurse satisfaction and side effects were compared between the two groups. quantitative data were compared using the unpaired Student"s t- test and categorical variables with Chi-square test
Results: Pre-operative sedation, response to parental separation and venepuncture were similar among the two groups. The dexmedetomidine grouo had a significantly lower incidence and severity of emergence agitation. Recovery nurse satisfaction was also higher in the dexmedetomidine group. However, incidence of bradycardia and hypotension was more.
Conclusion: Premedication with oral dexmedetomidine is as effective as oral midazolam and produces lesser emergence agitation, though side effects like hypotension and bradycardia may occur
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 1.00 Year(s) to 6.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Belonging to the American Society of Anesthesiologist physical status Ι Posted for elective herniotomy under general anesthesia.
Exclusion Criteria
- •Patients with a known allergy to the study drugs Mental retardation Neurobehavioral problems.
Outcomes
Primary Outcomes
Level of sedation, parental separation anxiety, IV acceptability
Time Frame: Before induction of anaesthesia
Secondary Outcomes
- Nurse satisfaction, emergence delirium(After surgery)