| CTRI Number |
CTRI/2017/03/008110 [Registered on: 15/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
21/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of the drugs nasal Dexmedetomine and oral Midazolam for decreasing preoperative anxiety in children and their effect on post-operative recovery. |
|
Scientific Title of Study
|
Comparison of oral midazolam nasal dexmedetomidine for premedication in children effect on psychomotor recovery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reshma Mulla |
| Designation |
Student |
| Affiliation |
Post Graduate Institute of medical education and research |
| Address |
Department of Anaesthesia and Intensive care, 4th floor, Nehru hospital
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8195942459 |
| Fax |
|
| Email |
msgmebymistake@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neerja Bhardwaj |
| Designation |
Guide |
| Affiliation |
Post Graduate Institute of medical education and research |
| Address |
Department of Anaesthesia and Intensive care, 4th floor, Nehru hospital
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009521 |
| Fax |
|
| Email |
neerja.bhardwaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reshma Mulla |
| Designation |
Student |
| Affiliation |
Post Graduate Institute of medical education and research |
| Address |
Department of Anaesthesia and Intensive care, 4th floor, Nehru hospital
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8195942459 |
| Fax |
|
| Email |
msgmebymistake@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Neerja Bhardwaj |
| Address |
Department of anaesthesia & intensive care PGIMER sector 12 Chandigarh |
| Type of Sponsor |
Other [not applicable] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Reshma Mulla |
Post Graduate Institute Of Medical Education and Research |
6th floor Advanced Pediatric Center
Chandigarh
CHANDIGARH |
8195942459
msgmebymistake@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee Postgraduate Institute of Medical Education and Research Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N433||Hydrocele, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intranasal dexmedetomidine |
intranasal dexmedetomidine was used for premedication at the dose of 1mcg/kg along with oral placebo |
| Comparator Agent |
oral midazolam |
oral midazolam was used at the dose of 0.5mg/kg for pemedication along with intranasal placebo |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
1. 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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| Effect of premedication on anxiolysis and sedation |
before premedication and 40 minutes after premedication |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2014 |
| Date of Study Completion (India) |
12/05/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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. |