Efficacy of intrabuccal ketamine for sedation

Comparison of the efficacy of intrabuccal ketamine and oral midazolam for sedation in children with oral procedures

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180129038549N7

Enrollment

100

Registered

2018-09-22

Start date

2018-07-31

Completion date

Unknown

Last updated

2018-10-11

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

Conditions

Oral procedure.

Interventions

Intervention 1: Intervention group: Intrabuccal ketamine 3 mg/kg. Intervention 2: Control group: Oral midazolam 0.5 mg/kg.

Eligibility

Sex/Gender

All

Age

6 Months to 12 Years

Inclusion criteria

Inclusion criteria: Required oral procedures Take informed consent

Exclusion criteria

Exclusion criteria: Sensitivity to benzodiazepines Low blood pressure Having a lung disease Having Nervous-Muscular Disorders Known contraindications to study drug

Design outcomes

Primary

Measure	Time frame
Sedation level of the patient. Timepoint: Every 5 minutes after drug administered. Method of measurement: Physical exam.	—

Secondary

Measure	Time frame
Side effects. Timepoint: Every 5 minutes after drug administered. Method of measurement: Physical exam.;Blood oxygen saturation level. Timepoint: Every 5 minutes after drug administered. Method of measurement: Physical exam.;The time interval from taking the drugs to the adequate sedation. Timepoint: Every 5 minutes after drug administered. Method of measurement: Record time.;The time interval from taking the drug to the child's full consciousness. Timepoint: Every 5 minutes after drug administered. Method of measurement: Record time.;The parents' satisfaction. Timepoint: After the child's consciousness. Method of measurement: Question from parents.;Pulse rate per minute. Timepoint: Every 5 minutes after drug administered. Method of measurement: Physical exam.;Respiratory rate per minute. Timepoint: Every 5 minutes after drug administered. Method of measurement: Physical exam.	—

Measure

Time frame

Side effects. Timepoint: Every 5 minutes after drug administered. Method of measurement: Physical exam.;Blood oxygen saturation level. Timepoint: Every 5 minutes after drug administered. Method of measurement: Physical exam.;The time interval from taking the drugs to the adequate sedation. Timepoint: Every 5 minutes after drug administered. Method of measurement: Record time.;The time interval from taking the drug to the child's full consciousness. Timepoint: Every 5 minutes after drug administered. Method of measurement: Record time.;The parents' satisfaction. Timepoint: After the child's consciousness. Method of measurement: Question from parents.;Pulse rate per minute. Timepoint: Every 5 minutes after drug administered. Method of measurement: Physical exam.;Respiratory rate per minute. Timepoint: Every 5 minutes after drug administered. Method of measurement: Physical exam.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarhad Heydari

Esfahan University of Medical Sciences

drfarhadheydari@gmail.com+98 31 3776 9818

Outcome results

None listed

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