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To compare effects of two sedative medications - fentanyl and midazolam - given in mist form through mask to children before surgery.

Comparison of nebulized fentanyl and nebulized midazolam as sedative premedication in pediatric patients : A randomized, double blinded study. - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072296
Enrollment
72
Registered
2024-08-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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: Midazolam as premedication: Midazolam as premedication for sedation prior to surgery Intervention2: Fentanyl as Premedication: Premedication with Fentanyl as sedation for 30 minutes pr

Sponsors

MS Ramaiah Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients between 2-6 years old undergoing elective surgeries under general anaesthesia Patients belonging to American Society of Anaesthesiologists 1 and 2

Exclusion criteria

Exclusion criteria: Patients with difficult airway Patients with central nervous system dysfunction Patients with behavourial disorders Patients with drug allergy Patients with intranasal pathology Patients with congenital anomaly Parent rejection or refusal

Design outcomes

Primary

MeasureTime frame
Time of onset of sedationTimepoint: Time of onset of sedation will be assessed when the sedation score is 3 during premedication (30 minus prior to surgery)

Secondary

MeasureTime frame
parental anxiety separation at 30 minutes maximum level of sedation at the end of 30 minutes mask acceptance scale score hemodynamic parametersTimepoint: Parental separation will be assessed at 30 mins of administration of the drug Maximum Level of sedation will be assessed at 30 mins of administration of drug Mask acceptance by the child will be assessed after shifting to operation theatre Hemodynamic parameters will be assessed at baseline,every 5 minute interval untill 30 minutes of administration of drug

Countries

India

Contacts

Public ContactDr Geetha C R

M S Ramaiah Medical College

jageedha@yahoo.com9900482828

Outcome results

None listed

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