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Comparison of Meperidine versus Midazolam Sedation in Uncooperative children

A Comparison of 2 Oral Sedation Regimens: Hydroxyzine-Midazolam and Hydroxyzine -Meperidine with oral Hydroxyzine-submucosal Meperidine in Dental Sedation of uncooperative 2-6 years of age children

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201101181861N2
Enrollment
78
Registered
2011-04-30
Start date
2010-05-24
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

Anxiety. Phobic anxiety disorder of childhood

Interventions

Intervention 1: InterventionGroup B (Midazolam-Hydroxyzine): in this group, Hydroxyzine is administered with a dose of 1mg/kg at first, after 30 minutes Midazolam (0.5 mg/kg in mixture with the same v
Treatment - Drugs
InterventionGroup B (Midazolam-Hydroxyzine): in this group, Hydroxyzine is administered with a dose of 1mg/kg at first, after 30 minutes Midazolam (0.5 mg/kg in mixture with the same volume of 10% sug
Intervention group C (Oral Meperidine-Hydroxyzine): in this group both meperidine (2mg/kg) and hydroxyzine (1mg/kg) are administered simultaneousnessly 1 hour before treatment
Control Group (submucosal injection of meperidine-Hydroxyzine): in this group, Hydroxyzine (1mg/kg) is administered one hour before treatment. After 30 minutes of hydroxyzine administration, meperidin

Sponsors

Dental Research Center, Shahid Beheshti Dental School
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age between 2-6 years; Behavior: Negative or completely negative according to Frankl rating scale; Health status: ASA I; should have at least 3 consecutive similar treatment sessions. Exclusion criteria: history of allergic reactions to Benzodiazepines or any other drug used in the study; Previous complications with general anesthesia in patient or family; Hyper trophic adenoids in a manner that occupied more than 50% of pharyngeal space (Brodsky 2+>); Sleep apnea.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Sleepness. Timepoint: Once(at the beginning of the treatment). Method of measurement: Observation.;Movement. Timepoint: During the process of treatment. Method of measurement: Observation.;Crying. Timepoint: During the process of treatment. Method of measurement: Observation.;Overall behavior. Timepoint: During the process of treatment. Method of measurement: Observation.;Fear of Dentistry. Timepoint: Before treatment and after the final session. Method of measurement: questionnaire.;Recovery time. Timepoint: After treatment completion. Method of measurement: Observation.;Respiratory Rate. Timepoint: At the beggining of the study and then every 15 minutes. Method of measurement: Monitoring.;Blood Pressure. Timepoint: At the beggining of the study and then every 15 minutes. Method of measurement: Monitoring.;Oxygen Saturation. Timepoint: At the beggining of the study and then every 15 minutes. Method of measurement: Monitoring.

Secondary

MeasureTime frame
Adverse reactions. Timepoint: During and after treatment. Method of measurement: Observation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMs Asgari

Shahid Beheshti Dental school

Iceberg2008@yahoo.com+98 21 2240 3010

Outcome results

None listed

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