FindTrial
Sign In

Comparing one drug used to sedate and decrease anxiety in children using two different routes posted for surgery under general anaesthesia

COMPARISON OF ORAL MIDAZOLAM WITH INTRANASAL MIDAZOLAM FOR PREMEDICATION IN PEDIATRIC PATIENTS -A RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038369
Enrollment
80
Registered
2021-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Control Intervention1: MIDAZOLAM: COMPARING ORAL ADMINISTRATION OF MIDAZOLAM WITH INTRANASAL MIDAZOLAM ADMINISTRATION FOR PREMEDICATION IN PEDIATRIC CHILDREN UNDERGOING ELECTIVE SURGERY UNDER GENERAL

Sponsors

NONE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: pediatric age group 1 -5 years ASA grade 1 and 2 patients undergoing elective surgeries under general anaesthesia

Exclusion criteria

Exclusion criteria: refusal of informed consent haemodynamic instability emergency surgeries fever or infection patient with recent history and active nasal bleeding patient with nasal mass

Design outcomes

Primary

MeasureTime frame
to compare the sedation achieved at 30 minutes after administration of midazolam either through oral route or intranasal routeTimepoint: BASELINE TO 30 MINUTES AFTER INTRODUCTION OF DRUG—

Secondary

MeasureTime frame
to evaluate quality of parental separation to evaluate acceptance of drug through oral or nasal route to evaluate ease of mask acceptance during preoxygenationTimepoint: baseline TILLN 20 MINUTES AFTER INTRODUCTION OF THE DRUG—

Countries

India

Contacts

Public ContactDR SHILPA GOYAL

ALL INDIA INSTITUTE OF MEDICAL SCIENCES ,JODHPUR

drshilpagoyal@yahoo.com9886210396

Outcome results

None listed

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