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Comparison of oral and buccal midazolam for pediatric dental sedation

Comparison of oral and buccal midazolam for pediatric dental sedation: A randomized, cross-over, clinical trial for efficacy, acceptance and safety

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013020312350N1
Enrollment
18
Registered
2013-05-11
Start date
2011-10-23
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

Stress in healthy uncooperative dental patient.

Interventions

Intervention 1: Group 1 received 0.5 mg/kg oral Midazolam syrup (Amsed, 2.5 mg/ml, Dales Pharmaceutical, England) 30 -45 minutes before treatment. Intervention 2: Group 2 was given 0.3 mg/kg buccal Mi
Treatment - Drugs
Group 1 received 0.5 mg/kg oral Midazolam syrup (Amsed, 2.5 mg/ml, Dales Pharmaceutical, England) 30 -45 minutes before treatment
Group 2 was given 0.3 mg/kg buccal Midazolam (Epistatus, 10mg/ml, Special Product Ltd, England), 15-30 minutes prior dental procedure. The other regimen was used at the second appointment.

Sponsors

Dental school- Shahed University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: those who needed bilateral and identical restorative and pulp treatment requiring 2 or more dental visits and were unable to tolerate the dental procedure with behavior management techniques. Those with contraindication to Midazolam, upper respiratory tract infection, tonsilar hypertrophy were excluded.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Stress. Timepoint: At discharge. Method of measurement: VAS.;Parents acceptebility. Timepoint: At discharge. Method of measurement: Questionnaire.;Physiologic outcomes. Timepoint: Before treatment,each 10 minutes, at discharge. Method of measurement: Pulse oximeter.

Secondary

MeasureTime frame
Parental acceptability. Timepoint: Discharge time. Method of measurement: Questionnair.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSara Tavassoli

Shahed University

tavasolisara@yahoo.com+98 21 8895 9210

Outcome results

None listed

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