effect of oral-pregabalin in children with dental anxiety

efficacy and safety of premedication with single dose of oral" pregabalin" in children with dental anxiety

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201206131674N2

Enrollment

Registered

2012-07-02

Start date

2012-06-14

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

children with dental anxiety. Phobic anxiety disorder of childhood

Interventions

Intervention 1: Patients are divided into two categories: The first meeting of "placebo" one hour before treatment is given to the patient. The patient's parents before feeding to the child's medicati

Treatment - Drugs

Patients are divided into two categories: The first meeting of "placebo" one hour before treatment is given to the patient. The patient's parents before feeding to the child's medication and one hour

At the second meeting "oral Pregabalin" up to 75 mg one hour before treatment is given to the patient. The patient's parents before feeding to the child's medication and one hour after the information

Eligibility

Sex/Gender

All

Age

5 Years to 7 Years

Inclusion criteria

Inclusion criteria: a) Age: 5-7, b) Mentally and physically healthy (ASAI), c) Informed consent from the parents or legally guardians, d) CFSS-DS score should be 38 or more at the screening visit, e) each patient should have at least 2 posterior primary teeth which need pulpotomy treatment. Patients will be excluded from the study if any of the above mentioned criteria being lost.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Visual Analogue Scale for Anxiety. Timepoint: Initial examination session, 5 minutes before taking the drug, an hour after taking the medicine and before discharge. Method of measurement: 100 mm during the two leftmost and right, respectively, which indicates are "no anxiety" and "extremely anxious".;Visual Analogue Scale for Sedation. Timepoint: Initial examination session, 5 minutes before taking the drug, an hour after taking the medicine and before discharge. Method of measurement: Line is 100 mm and the patient's sedation from left to right, respectively, of "not quiet at all" to "extremely slow by" grading does.;Ramsay scale. Timepoint: Initial examination session, 5 minutes before taking the drug, an hour after taking the medicine and before discharge. Method of measurement: Sedation can be divided into 6 levels.	—

Measure

Time frame

Visual Analogue Scale for Anxiety. Timepoint: Initial examination session, 5 minutes before taking the drug, an hour after taking the medicine and before discharge. Method of measurement: 100 mm during the two leftmost and right, respectively, which indicates are "no anxiety" and "extremely anxious".;Visual Analogue Scale for Sedation. Timepoint: Initial examination session, 5 minutes before taking the drug, an hour after taking the medicine and before discharge. Method of measurement: Line is 100 mm and the patient's sedation from left to right, respectively, of "not quiet at all" to "extremely slow by" grading does.;Ramsay scale. Timepoint: Initial examination session, 5 minutes before taking the drug, an hour after taking the medicine and before discharge. Method of measurement: Sedation can be divided into 6 levels.

—

Secondary

Measure	Time frame
Nausea. Dizziness and drowsiness. Skin allergy. Blurred vision. Timepoint: During and after procedure. Method of measurement: Direct observation by the physician and patient reports.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTahereh Eskandarian

Shiraz University Of Medical Sciences

eskandarian_t@yahoo.com00

Outcome results

None listed

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