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A clinical study to compare two oral drugs midazolam and dexmedetomidine to calm children before surgery.

A prospective, randomized, double-blinded control study on comparison of oral midazolam and dexmedetomidine as premedication in children.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/12/010874
Enrollment
60
Registered
2017-12-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Children who are scheduled for surgeries meeting inclusion criteria are included in the study. Health Condition 2: R69- Illness, unspecified

Interventions

Intervention1: Oral drug administration: One of the selected drugs is administered orally 45 minutes before surgery. Control Intervention1: Midazolam and Dexmedetomidine: One of the two drugs is given

Sponsors

SRM Medical College Hospital and Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA grade I-II undergoing elective surgeries 2. Weighing between 10 to 30 kg.

Exclusion criteria

Exclusion criteria: 1. Children with developmental delay or mental retardation. 2. Children with other coexisting systemic illness. 3. Patient with known allergies to the study drugs. 4. Any child vomiting or spitting out the premedication drug after oral administration.

Design outcomes

Primary

MeasureTime frame
Mask acceptance on inductionTimepoint: Mask acceptance was assessed using a 5-point scale. 1) combative, crying 2) moderate fear of mask, not easily calmed 3) cooperative with reassurance 4) calm, cooperative 5) asleep, steal induction.

Secondary

MeasureTime frame
Response of child to parental separationTimepoint: It will be graded as 1) crying, cannot be reassured. 2) awake, anxious, can be easily reassured 3) good separation, awake, calm 4) asleep;SedationTimepoint: The sedation achieved at the end of 45 minutes will be noted as per following scale. 1) anxious, depressed/ agitated/crying 2) awake, calm, quiet 3) drowsy, responds to verbal commands/gentle stimulation, 4) asleep

Countries

India

Contacts

Public ContactRajagopalan Venkatraman

Srm Medical College Hospital and Research Centre

natraj892@gmail.com9790872056

Outcome results

None listed

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