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Comparison of drugs for Premedication in the form of popsicles for elective pediatric surgeries.

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047095
Enrollment
78
Registered
2022-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z412- Encounter for routine and ritual male circumcision Health Condition 2: N433- Hydrocele, unspecified Health Condition 3: Q549- Hypospadias, unspecified Health Condition 4: K409- Unilateral inguinal hernia, without obstruction or gangrene Health Condition 5: S829- Unspecified fracture of lower leg

Interventions

Intervention1: 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 flavoure

Sponsors

Saveetha Medical College Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Elective surgeries -Weighing between 10 kgs- 40 kgs -Procedures lasting more than 30 min -ASA I or II patients

Exclusion criteria

Exclusion criteria: -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

Design outcomes

Primary

MeasureTime frame
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) Timepoint: -To assess the parental separation at 10min, 20min, 30min after administration of popsicle This is done for all the three groups.—

Secondary

MeasureTime frame
-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 Timepoint: -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.—

Countries

India

Contacts

Public ContactReesha Joshi

Saveetha Medical College And Hospital

reesha.joshi@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026