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Comparison of the drugs nasal Dexmedetomine and oral Midazolam for decreasing preoperative anxiety in children and their effect on post-operative recovery.

Comparison of oral midazolam nasal dexmedetomidine for premedication in children effect on psychomotor recovery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/008110
Enrollment
100
Registered
2017-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: N433- Hydrocele, unspecified

Interventions

Intervention1: intranasal Dexmedetomidine: intranasal dexmedetomidine was compared with oral midazolam for premedication in children Intervention2: intranasal dexmedetomidine: intranasal dexmedetomidi

Sponsors

Dr Neerja Bhardwaj
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 100 children of age 2 – 10 years (weight =25 kg) and ASA physical status I or II undergoing minor surgical procedures (surgical duration 1.5 h approximately), were enrolled in the study.

Exclusion criteria

Exclusion criteria: 1. Allergy or hypersensitive reaction to dexmedetomidine or midazolam 2. Organ dysfunction, cardiac arrhythmia or congenital heart disease 3. Mental retardation 4. Severe dysfunction of CNS or raised intracranial pressure

Design outcomes

Primary

MeasureTime frame
To compare oral midazolam & intranasal dexmedetomidine for their effects on psychomotor recovery in children undergoing elective surgical procedures under general anaesthesiaTimepoint: before premedication (T0)postoperatively when aldrete score of 9 or more is achieved(T1)and if T1 is different from T0 then tests will be repeated after 1 hour of T1(T2)—

Secondary

MeasureTime frame
Effect of premedication on anxiolysis and sedationTimepoint: before premedication and 40 minutes after premedication—

Countries

India

Contacts

Public ContactDr Reshma Mulla

Post Graduate Institute of medical education and research

neerja.bhardwaj@gmail.com7087009521

Outcome results

None listed

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