Comparison of intranasal midazolam and Dexmedetomidine

Comparison the sedative effect of intranasal administration of midazolam and Dexmedetomidine in uncooperative 4 to 6 years of age pediatriientsc dental pat

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201409141861N5

Enrollment

100

Registered

2014-09-23

Start date

2014-10-02

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

Sedation. Phobic anxiety disorder of childhood

Interventions

Intervention 1: Control: Midazolam 0.2 mg/kg, 15 minutes before dental treatment. The drug will be calculated by insulin syringe and sprayed without dilution in each nostril in 5 to 10 seconds inter

Treatment - Drugs

Control: Midazolam 0.2 mg/kg, 15 minutes before dental treatment. The drug will be calculated by insulin syringe and sprayed without dilution in each nostril in 5 to 10 seconds intervals in semi su

Intervention: Dexmedetomidine 1µg/kg 15 minutes before treatment. The drug will be calculated by insulin syringe and sprayed without dilution in each nostril in 5 to 10 seconds intervals in semi

Eligibility

Sex/Gender

All

Age

14 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Uncooperative pediatric dental patients; age 4 to 6 years; negative or definitely negatively Behavioral; healthy (ASA I); need at least one dental appointment including injection and pulp treatment. Exclusion criteria: History of allergy to either administered agents or other sedatives; sleep apnea; delayed in growth; mental retardation; allergic reaction to other sedatives or general anesthesia; nonacceptance of drug administration;upper respiratory infection or nasal secretions during the past two weeks.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Overall behavior. Timepoint: At the end of treatment session. Method of measurement: Houpt Sedation Rating Scale.;Sleep. Timepoint: During treatment. Method of measurement: Houpt Sedation Rating Scale.;Movement. Timepoint: During treatment. Method of measurement: Houpt Sedation Rating Scale.;Crying. Timepoint: During treatment. Method of measurement: Houpt Sedation Rating Scale.;Dental fear. Timepoint: At the end of treatment session. Method of measurement: Questinnaire.;Behavior problems. Timepoint: Before treatment. Method of measurement: SDQ Questionnaire.;?Arterial blood oxygen saturation (SpO2). Timepoint: Before drug administration, at the beginning of treatment, and then every 15 minutes until the end of treatment. Method of measurement: Pulse oximeter.;Heart rate. Timepoint: Before drug administration, at the beginning of treatment, and then every 15 minutes until the end of treatment. Method of measurement: Pulse oximeter.;Respiratory Rate. Timepoint: Before drug administration, at the beginning of treatment, and then every 15 minutes until the end of treatment. Method of measurement: Counting the number of chest movements by examiner.;Systolic and diastolic Blood Pressure. Timepoint: Before drug administration, at the beginning of treatment, and then every 15 minutes until the end of treatment. Method of measurement: Digital pressure measurement device.	—

Measure

Time frame

Overall behavior. Timepoint: At the end of treatment session. Method of measurement: Houpt Sedation Rating Scale.;Sleep. Timepoint: During treatment. Method of measurement: Houpt Sedation Rating Scale.;Movement. Timepoint: During treatment. Method of measurement: Houpt Sedation Rating Scale.;Crying. Timepoint: During treatment. Method of measurement: Houpt Sedation Rating Scale.;Dental fear. Timepoint: At the end of treatment session. Method of measurement: Questinnaire.;Behavior problems. Timepoint: Before treatment. Method of measurement: SDQ Questionnaire.;?Arterial blood oxygen saturation (SpO2). Timepoint: Before drug administration, at the beginning of treatment, and then every 15 minutes until the end of treatment. Method of measurement: Pulse oximeter.;Heart rate. Timepoint: Before drug administration, at the beginning of treatment, and then every 15 minutes until the end of treatment. Method of measurement: Pulse oximeter.;Respiratory Rate. Timepoint: Before drug administration, at the beginning of treatment, and then every 15 minutes until the end of treatment. Method of measurement: Counting the number of chest movements by examiner.;Systolic and diastolic Blood Pressure. Timepoint: Before drug administration, at the beginning of treatment, and then every 15 minutes until the end of treatment. Method of measurement: Digital pressure measurement device.

—

Secondary

Measure	Time frame
Intra-nasal drug acceptence. Timepoint: At the time of drug administeration. Method of measurement: Observation(Hass method).;Adverse effects including. Timepoint: Mucosal irritation, coughing, sneezing, nausia, vomitting. Method of measurement: Observation.	—

Countries

Iran (Islamic Republic of)

Contacts

Public Contactkatayoun salem

Guilan University of Medical Sciences

?esmaeeli@yahoo.com+98 13132636059

Outcome results

None listed

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