| CTRI Number |
CTRI/2024/12/078654 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparative |
| Study Design |
Other |
|
Public Title of Study
|
Giving midazolam drug which is used to calm and sedate vs fentanyl drug which is used for pain relieving and sedation through nebulisation for those who is undergoing general Aneasthesia surgery in age group of 2 to 8 years |
|
Scientific Title of Study
|
Comparison of effects of nebulised midazolam versus nebulised fentanyl as a premedication in the age group of 2 to 8 years of children undergoing general Aneasthesia |
| 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 Poornima Sonkamble |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of Aneasthesia, 6th Floor, JJ Hospital Main Building, GGMC Mumbai and Sir JJ Hospital, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9850961195 |
| Fax |
|
| Email |
pathadepoornima@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poornima Sonkamble |
| Designation |
Associate Professor |
| Affiliation |
JJ Hospital |
| Address |
Department of Aneasthesia, 6th Floor, JJ Hospital Main Building, GGMC Mumbai and Sir JJ Hospital, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9850961195 |
| Fax |
|
| Email |
pathadepoornima@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poornima Sonkamble |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of Aneasthesia, 6th Floor, JJ Hospital Main Building, GGMC Mumbai and Sir JJ Hospital, Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9850961195 |
| Fax |
|
| Email |
pathadepoornima@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Poornima Sonkamble |
| Address |
Department of Anesthesia, 6th floor, JJ Hospital Main Building, Sir JJ Hospital Mumbai |
| 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 Sameer Bansode |
JJ Hospital Mumbai |
GGMC Mumbai & Sir JJ hospital Mumbai, 400008
Mumbai
MAHARASHTRA |
9404821385
sameerbansode@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Drug Midazolam Vs Drug Fentanyl |
comparing the agent drug Midazolam versus Fentanyl in nebulized format as a premedication agent before undergoing the general anesthesia procedure |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of age group 2 to 8 years with physical status American Association of Anesthesiology (ASA) Class I and Class II.
2. Children belonging to either sex.
3. Children not having a history of:
a. Upper airway disease
b. CNS dysfunction
4. No Allergy to the drugs under study
5. Children’s undergoing general anesthesia
5. All children with guardian/parents who give consent to take the premedication.
6. Patients with no intranasal pathology or children with airway congenital anomaly.
|
|
| ExclusionCriteria |
| Details |
1. Children physical status American Association of Anesthesiology (ASA) Class III and Class IV
2. Children with pre-existing cardiovascular, renal, and hepatic disorders, Diabetes mellitus
3. Children known to have allergic reaction to opioids drugs.
a. Children allergic to either of study drugs
b. Patients with any intranasal pathology or children with any congenital anomaly.
c. Children refused to take the premedication due to any reasons.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objective- to evaluate.
i. Onset and Duration of Sedation.
ii. Acceptance of Mask and Other Non-Invasive Maneuver.
iii. Onset of Decrease of the Stress Response.
|
Primary objective- to evaluate.
i. Onset and Duration of Sedation.
ii. Acceptance of Mask and Other Non-Invasive Maneuver.
iii. Onset of Decrease of the Stress Response.
Secondary objective- to evaluate.
i. Hemodynamic variables (Heart Rate, Blood Pressure, O2 saturation)
  |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary objective- to evaluate.
i. Hemodynamic variables (Heart Rate, Blood Pressure, O2 saturation)
  |
Every 10 min |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2025 |
| Date of Study Completion (India) |
25/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/08/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Comparing the effects of nevbullised midazolam vs nebulised fentanyl as a premedication in 2 to 8 years of children undergoing the general anesthesia. As children’s are more afraid of invasive procedure and hospital environment, we emphasise on the smooth parental separation and preparation of child’s for the surgery which won’t cause traumatic experience to child. |