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Evaluation of Midazolam Efficacy and Safety

Comparison of efficacy and safety of "Midazolam Syrup" versus" PO Midazolam " in dental treatment of uncooperative 4-6 years old patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201302031861N4
Enrollment
82
Registered
2013-02-08
Start date
2013-01-02
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

Anxiety, Uncooperation in Pediatric Dental Treatment. Phobic anxiety disorder of childhood

Interventions

Intervention: PO midazolam 2.5 mg/ml Control: mdazolam surup Amsed 2.5 mg/ml.
Treatment - Drugs
Intervention: PO midazolam 2.5 mg/ml Control: mdazolam surup Amsed 2.5 mg/ml

Sponsors

Guilan University of Medical Sciences, Deputy of Research and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Uncooperative behavior (Frankl 1,2); age 4 to 6 years; ASA I Exclusion criteria: Hypertrophic tonsils /adenoids (Brodsky>2); weight >24 kg; History of allergy to Benzodiazepines; Sleep apnea; history of common cold/ Respiratory disease during the past two weeks.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Sedation. Timepoint: Sedation: At the time of injection, cavity preparation and restoration. Method of measurement: By the means of North Carolina Behavior Rting Scale.;Physiological parameters(Systoic and diastolic Blood pressure), Heart rate, Respiratory rate, SPO2. Timepoint: Before drug administration, at the onset of treatment, and then every 15 minutes. Method of measurement: Blood pressure:Digital blood pressure cuff,Heart rate: pulse oximeter, Respiratory rate: counting the breathing movements of thorax, SPO2: Pulseoximeter.

Secondary

MeasureTime frame
Dental fear, General Anxiety, Child's personality (different aspects). Timepoint: Before treatment. Method of measurement: Questionnaires: CFSS-DS, SDQ, Conner's parental rating scale.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKatayoun Salem

Guilan Dental School

k_salem@gums.ac.ir+98 13 1326 3605

Outcome results

None listed

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