| CTRI Number |
CTRI/2022/11/047095 [Registered on: 07/11/2022] Trial Registered Prospectively |
| Last Modified On: |
14/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of drugs for Premedication in the form of popsicles for elective pediatric surgeries. |
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Scientific Title of Study
|
Comparison of popsicles of oral midazolam, ondansetron, Ketamine and Atropine (MOKA) vs midazolam, Ondansetron and Atropine (MOA) vs Ketamine, Ondansetron and Atropine (KOA) as oral premedication for elective pediatric surgeries |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reesha Joshi |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Medical College And Hospital |
| Address |
Department of Anesthesia, 2nd floor, OT complex, Saveetha Medical College and Hospital, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
|
| Fax |
|
| Email |
reesha.joshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Reesha Joshi |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Medical College And Hospital |
| Address |
Department of Anesthesia, 2nd floor, OT complex, Saveetha Medical College and Hospital, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
|
| Fax |
|
| Email |
reesha.joshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reesha Joshi |
| Designation |
Assistant Professor |
| Affiliation |
Saveetha Medical College And Hospital |
| Address |
Department of Anesthesia, 2nd floor, OT complex, Saveetha Medical College and Hospital, Thandalam, Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
|
| Fax |
|
| Email |
reesha.joshi@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Saveetha Medical College Hospital |
| Address |
Saveetha Nagar, Thandalam, Chennai, Tamil Nadu 602105 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Reesha Joshi |
Saveetha Medical College And Hospital |
Department of Anaesthesiology,
Operation Theatre,
Saveetha Medical College And Hospital, Thandalam, Chennai 602105.
Chennai
TAMIL NADU |
7094640487
reesha.joshi@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College And Hospital Institutional Ethics Committee(SMCH-IEC) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z412||Encounter for routine and ritual male circumcision, (2) ICD-10 Condition: N433||Hydrocele, unspecified, (3) ICD-10 Condition: Q549||Hypospadias, unspecified, (4) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (5) ICD-10 Condition: S829||Unspecified fracture of lower leg, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group KOA- Ketamine, Ondansetron, Atropine |
1 popsicle (10ml) would contain: ketamine 2ml (100 mg), Ondansetron 2 ml (8 mg), Atropine 1ml (0.6 mg) and with 5ml of orange colour flavoured drink. This was given once preoperatively. |
| Comparator Agent |
Group MOA - Midazolam, Ondansetron, Atropine |
1 popsicle (10ml) would have midazolam 1.5 ml of ampoule containing 5mg (7.5 mg), Ondansetron 2 ml (8 mg), Atropine 1ml (0.6 mg) and 5.5ml of orange colour.
This was given once preoperatively. |
| Comparator Agent |
Group MOKA- Midazolam, Ondansetron, Ketamine, Atropine |
1 popsicle (10ml) would consist of oral Midazolam 0.5 ml of preparation containing 5mg/cc (2.5 mg), Ondansetron 2 ml (8 mg), Ketamine 1.5 ml (75 mg) Atropine 1ml (0.6mg) with 6ml of orange colour flavoured drink. This was given once preoperatively. |
|
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Inclusion Criteria
|
| Age From |
1.50 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
-Elective surgeries
-Weighing between 10 kgs- 40 kgs
-Procedures lasting more than 30 min
-ASA I or II patients
|
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| ExclusionCriteria |
| Details |
-ASA III or higher, congenital heart defects ,hypo or hyperthyroidism or any other endocrinal disturbances, severe CNS dysfunction, severe liver and renal disease, risk of aspiration, severe systemic illness, Respiratory tract infection (URI/LRTI)
-Emergency cases |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
To compare the separation anxiety in pediatric patients between the three groups MOKA (Midazolam+Ondansetron+Ketamine+Atropine), MOA (Midazolam+Ondansetron, Atropine), KOA (Ketamine+ Ondansetron+Atropine)
|
-To assess the parental separation at 10min, 20min, 30min after administration of popsicle
This is done for all the three groups.
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
-To compare the Sedation score between the three groups.
-To compare the ease of venous cannulation between the three groups.
-To compare the mask acceptance between the three groups.
-To compare the time of extubation between the three groups.
-To compare the post anesthetic recovery between the three groups.
-To compare the adverse effects between the three groups
|
-To assess the sedation score at 10min, 20min, 30min after administration of popsicle
-To assess the ease of venous cannulation and mask acceptance before induction of anesthesia
-To asess the time taken for extubation and time taken to achieve a modified Aldrete score of more than 9, immediately after extubation
-To note the side effects upto 24 hours postoperatively.
This is done for all three groups. |
|
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Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2022 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Introduction: Premedication is widely used in pediatric anesthesia for sedation and anxiolysis. The fear of surgery and anxiety will be present in children and their parents. An ideal premedication should relieve anxiety, facilitate parenteral separation, acceptance of IV cannula and face mask. Its Incidence are higher in pre-school children. Most anesthesiologists use either presence of parent or sedative premedication during induction. Separation from parents and induction of anesthesia are the vital stress factors for children in the perioperative period. A good premedication in pediatric age group should be easy to use, should have rapid onset and short duration of action with less side effects. Aim: To investigate whether combination of midazolam and ketamine in reduced dose as popsicles has the advantages of improved sedation with faster recovery and fewer adverse effects compared to single agents. Hypothesis: Combining midazolam and ketamine in reduced dose as ice cubes will provide better sedation and parenteral separation in pediatric cases when compared to giving separately in regular dose.
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