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A Comparison of Midazolam and Dexmedetomidine as Medication to be given in Nose before Anesthesia in Lower Body Surgeries of Children

A Comparative Analysis of Intranasal Midazolam and Intranasal Dexmedetomidine as Premedication in Pediatric Infraumbilical Surgeries: A Prospective Randomized Double-blind Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019711
Enrollment
70
Registered
2019-06-17
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: Q00-Q99- Congenital malformations, deformations and chromosomal abnormalities

Interventions

Intervention1: Dexmedetomidine: Intranasal instillation 30 minutes prior to induction of anesthesia in dose of 0.5 mcg per kg body weight over duration of 30 seconds once only Control Intervention1: M

Sponsors

Dr Aikta Gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children undergoing infraumbilical surgeries 2. ASA grade I and II

Exclusion criteria

Exclusion criteria: 1. Patients having known allergy to the drugs used in study 2. Patients having upper respiratory infection 3. Patients having neurological disorders 4. Patients under treatment with anticonvulsants/sedatives 5. Patients spitting out the medication

Design outcomes

Primary

MeasureTime frame
Preoperative Sedation ScoreTimepoint: Prior to administration of study drugs and thereafter every 10 minutes till patients in shifted into operating room

Secondary

MeasureTime frame
Immediate postoperative sedation scoreTimepoint: After completion of surgery and shifting into post anesthesia care unit;Mask acceptance score Timepoint: At the time of induction of anesthesia;Parental separation scoreTimepoint: At the time of shifting into operating room;Postoperative emergence (Cravero score)Timepoint: After completion of surgery and shifting into post anesthesia care unit;Preoperative and intraoperative vital parameters Timepoint: Prior to administration of study drugs and thereafter every 10 minutes until completion of surgery and shifting of patient into post anesthesia care unit

Countries

India

Contacts

Public ContactDr Payaswinee Sharma

Chacha Nehru Bal Chikitsalaya, New Delhi

payaswinee87@gmail.com9200022287

Outcome results

None listed

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