| CTRI Number |
CTRI/2025/10/095769 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study to evaluate the efficacy of intranasal dexmedetomidine versus intranasal midazolam as premedication in pediatric age group. |
|
Scientific Title of Study
|
Comparative study to evaluate the efficacy of intranasal dexmedetomidine versus intranasal midazolam as premedication in pediatric age group. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Salma Sultana |
| Designation |
Secondary dnb resident |
| Affiliation |
Hindu Rao Hospital |
| Address |
A-18 Malka Ganj
North DELHI 110007 India |
| Phone |
9836169477 |
| Fax |
|
| Email |
drsalma989@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Salma Sultana |
| Designation |
Secondary dnb resident |
| Affiliation |
Hindu Rao Hospital |
| Address |
A-18 Malka Ganj
North DELHI 110007 India |
| Phone |
919836169477 |
| Fax |
|
| Email |
drsalma989@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Salma Sultana |
| Designation |
Secondary dnb resident |
| Affiliation |
Hindu Rao Hospital |
| Address |
A-18 Malka Ganj
North DELHI 110007 India |
| Phone |
9836169477 |
| Fax |
|
| Email |
drsalma989@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
North DMC medical college and Hindu Rao Hospital |
| Address |
Gandhi Square Malka Ganj Delhi 110007 |
| Type of Sponsor |
Government medical college |
|
|
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 Salma Sultana |
North DMC Medical College and Hindu Rao Hospitall |
Gandhi square Malka Ganj
Department of Anaesthesia
110007
North DELHI |
9836169477
drsalma989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee North DMC Medical College And Hindu Rao Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine and Midazolam |
Intranasal instillation 1.5 ug/kg and 0.1mg/kg |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 1 Yr to 12 yrs
Patients weight between 7.5kgs -45kgs
Patients belonging to ASA grade I & II
Patients undergoing elective procedure under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients refusing to participate
Patients with risk of pulmonary aspiration
Patients with history of difficult intubation
MM score 3&4
Patients with reactive airway and spine deformity
Patients with history of cardiac,respiratory, renal or hepatic disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess all patients for ease of sedation using Ramsay 6 point sedation score |
To assess all patients for ease of sedation using Ramsay 6 point sedation score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assess secondary parameters such as blood pressure heart rate & oxygen saturation
Assess child parents separation score
Mask acceptance score
Any adverse reactions |
30 minutes after premedication |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The intra nasal administration of midazolam has shown to be very effective,easy,a non-invasive route with better acceptance, higher safety,rapid onset of action with higher bioavailability due to the vascularization of nasal mucosa and bypassing hepatic metabolism. Dexmedetomidine (DEX) is a highly selective, short- acting, alpha 2-adrenoreceptor agonist used for conscious sedation, and analgesia perioperatively. It provides sedation, anxiolysis, and analgesic effects without causing respiratory depression. Dexmedetomidine has been extensively investigated in the pediatric population with increasing evidence supporting its use, including as premedication. The sedative property is thought to be due to G-proteins activation by the presence of alpha 2a receptors in the brainstem resulting in inhibition of norepinephrine release, with a short half-life and having a bioavailability of around (72.6–92.1%) when administered via the intranasal route. The intranasal mode of administration of dexmedetomidine has advantage over the intravenous mode in respect to ease of administration,higher bioavailability with minimal discomfort, provide sedation without respiratory depression, reduce emergence delirium and postoperative negative behaviour such as aggression. This study evaluates the efficacy of intranasal administered dexmedetomidine (Dose- 1.5 ug/kg ) compared to intranasal midazolam (0.1mg/kg) in pediatrics age group as per-medication. |