sedation in dentistry

A comparison of the sedative effectiveness of oral combinations of midazolam/ketamine and midazolam /hydroxyzine in uncooperative pediatric dental patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT138804092102N1

Enrollment

Registered

2010-01-16

Start date

2007-10-23

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

Dentistry-related anxiety. Phobic anxiety disorders

Interventions

either the combination of midazolam 0.5 mg/kg and ketamine 5mg/kg or midazolam 0.5 mg/kg and hydroxyzine 2 mg/kg prior to the beginning of dental treatment.

either the combination of midazolam 0.5 mg/kg and ketamine 5mg/kg or midazolam 0.5 mg/kg and hydroxyzine 2 mg/kg prior to the beginning of dental treatment

Eligibility

Sex/Gender

All

Age

3 Years to 5 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: uncooperative children, ages 37 to 56 months, in need of at least 2 restorative visits, parents acceptance. Exclusion criteria: vomiting before or during treatment.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Conscious sedation. Timepoint: 30 min in midazolam/ketamine group and 45 min in midazolam /hydroxyzine group. Method of measurement: observation-Houpt index.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahnaz Maghsoudi

Hamadan dentistry faculty

sh.maghsoudi@umsha.ac.ir, shm554@yahoo.com+98 81 1835 4016

Outcome results

None listed

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