Sedative effect of ketamine, midazolam and oral chloral hydrate in children

Comparison of the sedative effect of oral ketamine, midazolam and chloral hydrate in children candidate for noninvasive diagnostic procedures

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015010612642N9

Enrollment

Registered

2015-01-18

Start date

2014-08-23

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Oral sedation in children. Dissociative anaesthesia and sensory loss

Interventions

Intervention 1: Midazolam group, patients administered 0 / 5mg / kg orally midazolam, and every 5 minutes to allow the separation of children from their parents will controle. Intervention 2: ketamin

Treatment - Drugs

Midazolam group, patients administered 0 / 5mg / kg orally midazolam, and every 5 minutes to allow the separation of children from their parents will controle

ketamin group, patients administered 5mg / kg oraly ketamin, and every 5 minutes to allow the separation of children from their parents will controle

chlorate Hydrate group, patients administered 50mg / kg orally chlorate Hydrate, and every 5 minutes to allow the separation of children from their parents will controle

Eligibility

Sex/Gender

All

Age

2 Years to 10 Years

Inclusion criteria

Inclusion criteria: inclusion criteria: Candidate for CT scan; candidate for audiometry; age between 2 to 10 years old; ASA I,II exclusion criteria: History of taking sedative drugs, history of drug abuse, history of taking anticonvulsants, history of allergy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Time of separating from parents. Timepoint: Every 5 min after administration. Method of measurement: Based on the examination by the research team.;Sedation. Timepoint: Every 5 min after administration. Method of measurement: Based on the examination by the research team based on sedatin score.;Anxiety. Timepoint: Every 5 min after administration. Method of measurement: Based on the examination by the team on the anxiety sedation table.;The children move during the procedure. Timepoint: 0,15 and 30 minute after drug administration. Method of measurement: Based on the examination by the team on the anxiety sedation table.	—

Measure

Time frame

Time of separating from parents. Timepoint: Every 5 min after administration. Method of measurement: Based on the examination by the research team.;Sedation. Timepoint: Every 5 min after administration. Method of measurement: Based on the examination by the research team based on sedatin score.;Anxiety. Timepoint: Every 5 min after administration. Method of measurement: Based on the examination by the team on the anxiety sedation table.;The children move during the procedure. Timepoint: 0,15 and 30 minute after drug administration. Method of measurement: Based on the examination by the team on the anxiety sedation table.

—

Secondary

Measure	Time frame
Children waking time. Timepoint: Since taking oral medication. Method of measurement: Based on the examination by the team in minutes.;Nausea. Timepoint: After taking oral medication. Method of measurement: Questions from Parents.	—

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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