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Comparison of oral administration versus intramuscular Ketamine, Midazolam, Atropine combination on sedation in pediatric dentistry

Comparison of oral administration versus intramuscular Ketamine, Midazolam, Atropine combination on sedation in pediatric dentistry

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016030926983N1
Enrollment
31
Registered
2016-05-28
Start date
2016-09-22
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

Dental. Other dental caries

Interventions

Intervention 1: Children in control group receive cocktail of 10 mg/kg Ketamine, 0.2 mg/kg Midazolam and 0.02 mg/kg Atropine orally. Intervention 2: In intervention group, each child receive an inject
Treatment - Drugs
Children in control group receive cocktail of 10 mg/kg Ketamine, 0.2 mg/kg Midazolam and 0.02 mg/kg Atropine orally.
In intervention group, each child receive an injection cocktail of 6 mg/kg Ketamine, 0.05 mg/kg Midazolam and 0.02 mg/kg Atropine through the gluteal region at their first dental session.

Sponsors

Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 4 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Uncooperative children were confirmed by two pediatric dentists ranked as definitely negative the Frankel scale who referred for dental treatment under local anesthesia, requiring at least two dental visits for two similar dental treatments. Exclusion criteria: Having systemic disease, medical contradictions

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Ocular response. Timepoint: Every one hour. Method of measurement: Eyes closed or nystagmus present, eyes open or no nystagmus.;Response to voice. Timepoint: Every one hour. Method of measurement: None-incoherent.;Response to touch. Timepoint: Every one hour. Method of measurement: Not arousable, sleepy, awake.;Sedation. Timepoint: Every one hour. Method of measurement: Ocular response, response to voice and touch.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Amani

Babol University of Medical Sciences

neda_amani69@yahoo.com+98 11 3219 9592

Outcome results

None listed

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