Skip to content

A clinical trial to study the effects of two drugs, ketamine and midazolam as pre medicant in pediatric patient undergoing elective surgery

A study comparing nebulised ketamine and midazolam as pre medicant in pediatric patient undergoing elective surgery - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091128
Enrollment
60
Registered
2025-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: ketamine : ketamine(2mg/kg) diluted to final volume of 3mL of solution using 0.9% normal saline, nebulized to pediatric patients for 15 minutes before transfer to operating room and as

Sponsors

Pt BD Sharma PGIMS Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I & II scheduled to undergo various elective surgical procedures

Exclusion criteria

Exclusion criteria: 1. children with history of developmental delay 2. children with systemic illness like - cardiac diseases, neurological, liver and renal disease. 3.parents refusing to give consent. 4. known allergy or hypersensitivity to ketamine or midazolam

Design outcomes

Primary

MeasureTime frame
Comparison of level of sedation and effectiveness of nebulised ketamine and midazolam as premedicantTimepoint: From the time of administration of drug at every 5 mins interval for first 30 mins

Secondary

MeasureTime frame
To compare time of onset of action, ease of child-parent separation, ease of induction in operative room, and effect of two drugs on intra-operative hemodynamicsTimepoint: From the time of administration of drug at every 5 mins interval for first 30 mins

Countries

India

Contacts

Public ContactDr Mansi Sukhija

Pt BD Sharma PGIMS Rohtak

mansisukhija261097@gmail.com9728776410

Outcome results

None listed

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