| CTRI Number |
CTRI/2024/09/073323 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A randomized prospective study comparing the efficacy of dexmedetomidine versus midazolam administered through the nasal route for sedation in pediatric patients |
|
Scientific Title of Study
|
A randomized prospective study comparing intranasal dexmedetomidine versus intranasal midazolam for sedation in pediatric patients. |
| 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 NEETU YADAV |
| Designation |
PG 2nd year Anaesthesia |
| Affiliation |
Subharti medical college and hospital |
| Address |
Subharti Medical College and Hospital, Department of Anaesthesia, Meerut, U.P ,250005 Begam Hazrat Hostel, Subharti University, Meerut, U.P Meerut UTTAR PRADESH 250005 India |
| Phone |
9958421762 |
| Fax |
|
| Email |
neetuyadav445@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR NEETU YADAV |
| Designation |
PG 2nd year Anaesthesia |
| Affiliation |
Subharti medical college and hospital |
| Address |
Subharti Medical College and Hospital, Department of Anaesthesia, Meerut, U.P ,250005 Begam Hazrat Hostel, Subharti University, Meerut, U.P Meerut UTTAR PRADESH 250005 India |
| Phone |
9958421762 |
| Fax |
|
| Email |
neetuyadav445@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Neetu Yadav |
| Designation |
PG 2nd year Anaesthesia |
| Affiliation |
Subharti medical college and hospital |
| Address |
Subharti Medical College and Hospital, Department of Anaesthesia, Meerut, U.P ,250005 Begam Hazrat Hostel,Subharti university, meerut, U.P Meerut UTTAR PRADESH 250005 India |
| Phone |
9958421762 |
| Fax |
|
| Email |
neetuyadav445@gmail.com |
|
|
Source of Monetary or Material Support
|
| Subharti hospital and medical college, Depatment of Anaesthesia, Meerut, U.P, 250005 |
|
|
Primary Sponsor
|
| Name |
SUBHARTI MEDICAL COLLEGE AND HOSPITAL |
| Address |
SUBHARTI MEDICAL COLLEGE AND HOSPITAL , MEERUT 250001 |
| Type of Sponsor |
Private 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 Neetu Yadav |
Subharti hospital and medical college |
Subharti Medical College and Hospital, Department of Anaesthesia, Meerut 250005 Meerut UTTAR PRADESH |
09958421762
neetuyadav445@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee ( Medical ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Before entering into any procedure room, intranasal dexmedetomidine will be given intranasally using 2ml syringe in recumbent position at a dose 2mcg/kg. Sedation score is assesed by using Ramsay sedation score and Observers assessment of alertness/ sedation score till 40min or before till sedation being achieved. |
| Intervention |
Midazolam |
Before entering into any procedure room, intranasal midazolam is given at a dose 0.5mg/kg using the intranasal spray with the child in recumbent position and sedation to be observed using Ramsay sedation score and Observers assessment of alertness/sedation score till 40mins or before till sedation achieved. |
| Comparator Agent |
Sedation |
Sedation is being assessed by using Ramsay sedation score and Observers assessment of alertness/sedation score for 40 mins or beforehand till sedation is being achieved by comparing intranasal dexmedetomidine and intranasal midazolam.
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1 ASA CLASS I & II
2 Age from 1-12yrs.
3 Patients of either sex. |
|
| ExclusionCriteria |
| Details |
1 Children with an allergy to the study drug.
2 Children with organ dysfunction.
3 Children with any congenital heart disease.
4. Refusal by the parents. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of intranasal dexmedetomidine and intranasal midazolam in pediatric patient for sedation. |
40mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To compare hemodynamic changes in both the groups.
2 To compare side effects in both the groups, if any. |
40 MINS. |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
19/09/2024 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code Response (Others) - NIL
- Who will be able to view these files?
Response (Others) - NIL
- For what types of analyses will this data be available?
Response (Others) - NIL
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 19-08-2024 and end date provided 09-10-2028?
Response (Others) - NIL
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Prior to any operative procedure, children are often susceptible to fear & anxiety of being separated from parents & entering the operating room environment. Premedication plays an important role in allowing a smooth separation of the child from the parent. One of the ways, an anaesthesiologist can deal with this challenge is to sedate the child beforehand. Children tolerate oral and nasal route better than intravenous route for needle fear. Preoperative anxiety during any procedure in children is a major concern, approximately 60% of pediatric patients suffer preoperative anxiety. Children may become overtly uncooperative at the time of separation from parents.
Nasal premedication with midazolam and dexmedetomidine has been studied as alternatives to oral premedication and injectables with comparable results. Intranasal route is a non-invasive route well tolerated by the pediatric patient . Bioavailability is highly primarily due to rich vasculature in the nasal mucosa. Onset of action is quicker than other systemic routes. Drugs administered via the nasal route are rapidly absorbed into the systemic circulation because they do not pass through portal circulation.
Dexmedetomidine is a newer alpha 2 agonist with mopre selective alpha 2 : alpha 1 adrenoreceptor activity with a short half life. Since this drug has a neutral pH, it is virtually painless when given given intanasally and it is also tasteless and odourless. Recently, it has been recommended for procedural sedation in children. In addition to its sedative property, dexmedetomidine exerts analgesics and antiemetic effects. In comparison with other ana;lgesics and sedative agents, dexmedetomidine has minimal effects on respiration.
Midazolam is one of the most commonly used sedative premedication in pediatric anaesthesia. It is employed in a variety of surgical and non surgical procedures. Midazolam is water soluble benzodiazepine that works by inhibiting the GABA receptor. It has sedative and anxiolytic properties, which makes easier to perform any procedure. As midazolam has high hepatic clearance , avoidance of first pass metabolism offers greater systemic bioavailabilty. The beneficial effect of modazolam includes rapid sedation, anxiolytic and reduction of post operative nausea and vomiting. However, the major drawback is that atleast 50% children cry on administration because it transiently irritates nasal passage. |