A comparison of oral dexmedetomidine and oral midazolam as premedicants in children

Phase 4

Completed

• Conditions: Children undergoing herniotomy aged 1-6 years

• Registration Number: CTRI/2018/04/013062
• Lead Sponsor: Government Medical College Kozhikode

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-28
• Study Completion: 2017-09-28
• Last Update Posted: 2018-03-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of sedation, parental separation anxiety, IV acceptability	Before induction of anaesthesia

Secondary Outcome Measures

Name	Time	Method
Nurse satisfaction, emergence delirium	After surgery

Trial Locations

Locations (1)

Government Medical College. Kozhikode; 🇮🇳 Kozhikode, KERALA, India

Government Medical College. Kozhikode

🇮🇳Kozhikode, KERALA, India

Jumaila M

Principal investigator

9496809550

jumiahmed@yahoo.com