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Comparison of Sublingual Midazolam and Dexmedetomidine for Premedication in Children.

Comparison of Sublingual Midazolam and Dexmedetomidine for Premedication in Children.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24728
Enrollment
100
Registered
2010-12-11
Start date
2010-12-15
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Premedication in children scheduled for minor elective procedures such as inguinal hernia repair, circumcision and orchidopexy under general anaesthesia. Keywords: premedication,children midazolam, dexmedetomidine

Interventions

Children will be randomly allocated into two groups: 1. Group I - 0.25 mg/kg midazolam will be given sublingually (drug to be retained in the mouth without spitting or swallowing) by asking the chil
2. Group II- 1.5 µg/kg dexmedetomidine will be given sublingually (drug to be retained in the mouth without spitting or swallowing) by asking the child to place the tip of the tongue to the back of up

Sponsors

Dept of Anaesthesiology, Pain & Perioperative Medicine Sir Ganga Ram Hospital, New Delhi ,India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children with ASA physical status I or II; 2. Age between 1 and 12 years; 3. Children undergoing elective inguinall hernia repair, orchidopexy or circumcision, under general anaesthesia and caudal block.

Exclusion criteria

Exclusion criteria: 1. Known allergy or hypersensitive reaction to midazolam or dexmedetomidine; 2. Liver or renal dysfunction; 3. Cardiac arrhythmia or congenital heart disease; 4. Mental retardation; 5. Use of enzyme inducing medication e.g. phenobarbitone; 6. Upper respiratory tract infection.

Design outcomes

Primary

MeasureTime frame
1. Behaviour and sedation status of the child during separation from the parent and at induction of anaesthesia; 2. Mask acceptability of the child at induction of anaesthesia; 3. Perioperative changes in heart rate and blood pressure; 4. Behaviour status of the child at time of wake up from anaesthesia.

Secondary

MeasureTime frame
Time to discharge from post-anaesthesia care unit (PACU).

Contacts

Public ContactDeepanjali Pant

Dept of Anaesthesiology, Pain & Perioperative Medicine Sir Ganga Ram Hospital, New Delhi, India

deepanjalipant@gmail.com

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)