Effect of Oral Midazolam and Ketamine in Pediatric Sedation

Comparison of Oral Midazolam and Ketamine with Oral Midazolam and Promethazine in Pediatric Sedation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180717040509N2

Enrollment

102

Registered

2018-09-30

Start date

2014-11-22

Completion date

Unknown

Last updated

2018-11-05

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

Conditions

Pediatric Sedation.

Interventions

Intervention 1: Intervention group: Combination of Oral Midazolam (0.5 mg/kg) from Iran Pharmaceutical Chemistry Company and Oral Ketamine (5mg/kg) from Gmbh ROTEXMEDICA, Germany mixed with 20 cc frui

Eligibility

Sex/Gender

All

Age

2 Years to 10 Years

Inclusion criteria

Inclusion criteria: Pediatric between 2 to 10 years olds

Exclusion criteria

Exclusion criteria: Children with Upper Respiratory Tract Infection Dissatisfaction to participate in the study Grade 3, 4, 5 or 6 of American Anesthesiology Association (ASA) Use of Sedative and Narcotic drugs Prohibited for Sedation Head Truama History of Cardiovascular Disease Eye Trauma History of Central Nervous System (CNS)

Design outcomes

Primary

Measure	Time frame
Sedation. Timepoint: Every 5 minutes to 40 minutes. Method of measurement: Ramsay Sedation Scale.;Pediatric's behavior. Timepoint: Every 5 minutes to 40 minutes. Method of measurement: Houpt Checklist.;Crying Rate. Timepoint: Every 5 minutes to 40 minutes. Method of measurement: Houpt Checklist.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzad Bozorgi

Sari University of Medical Sciences

farzad722001@yahoo.com+98 11 3336 1700

Outcome results

None listed

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