Comparison of the drugs nasal Dexmedetomine and oral Midazolam for decreasing preoperative anxiety in children and their effect on post-operative recovery.

Completed

• Conditions: Hydrocele, unspecified,

• Registration Number: CTRI/2017/03/008110
• Lead Sponsor: Dr Neerja Bhardwaj

Brief Summary

**Primary aim** was to compare oral midazolam and nasal dexmedeomidine for their effects on psychomotor recovery in children undergoing elective surgical procedures under general anaesthesia

**Secondary aim**was to see the effect of premedication on anxiolysis and sedation.

Our study  was a Randomised, double blind, controlled trial

Inclusion criteria: 100 ASA I and II children of either sex of age 2 – 10 years  and weighing ≤25 kg were enrolled in the study. The duration of the procedure was ≤ 90 minutes. **Methodology:**MDZ group received oral midazolam 0.5mg/kg and nasal placebo where as DEX group received nasal dexmedetomidine 1mcg/kg and oral placebo.Children were familiarized with the tests on the morning of day of surgery.Tests performed prior to premedication was taken as T0 & postoperatively when Aldrete score of 9 or more was achieved was taken as T1. If the scores at T1 were different from T0, then the tests were repeated after 1 hour of aldrete score of 9  and was taken as T2.

**Results:**Mean time to reach Alderete score of 9 was 30 minutes in  Dex group whereas it was 39 minutes  in Mdz group(p=0.04) which was statistically significant but not clinically significant.Parental separation  score was good in both the groups (90% in group MDZ & 80% in group DEX). Better sedation scores was noted in Dex group  (67.7%) than MDZ group(53.1%) in younger age group whereas MDZ  group had better sedation scores in older age group when compared with DEX group (55.6% vs. 47.4%). Both midazolam & dexmedetomidine showed favourable sedation and parental separation scores. Children receiving midazolam showed favourable emotional score compared to those receiving dexmedetomidine.

**Conclusion:** Dexmedetomidine produces better psychomotor recovery than midazolam with the caveat of lesser effect on emotional score.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-15
• Study Completion: 2015-12-05
• Last Update Posted: 2024-04-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

100 children of age 2 – 10 years (weight ≤25 kg) and ASA physical status I or II undergoing minor surgical procedures (surgical duration 1.5 h approximately), were enrolled in the study.

Exclusion Criteria

• Allergy or hypersensitive reaction to dexmedetomidine or midazolam 2.
• Organ dysfunction, cardiac arrhythmia or congenital heart disease 3.
• Mental retardation 4.
• Severe dysfunction of CNS or raised intracranial pressure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare oral midazolam & intranasal dexmedetomidine for their effects on psychomotor recovery in children undergoing elective surgical procedures under general anaesthesia	before premedication | (T0)postoperatively when aldrete score of 9 or more is achieved(T1)and if T1 is different from T0 then tests will be repeated after 1 hour of T1(T2)

Secondary Outcome Measures

Name	Time	Method
Effect of premedication on anxiolysis and sedation	before premedication and 40 minutes after premedication

Trial Locations

Locations (1)

Post Graduate Institute Of Medical Education and Research; 🇮🇳 Chandigarh, CHANDIGARH, India

Post Graduate Institute Of Medical Education and Research

🇮🇳Chandigarh, CHANDIGARH, India

Dr Reshma Mulla

Principal investigator

8195942459

msgmebymistake@gmail.com