Evaluation of the effect of local anesthesia in pain control in children during dental treatment under general anesthesia

Investigation of the hemodynamic and pain control effects of local anesthesia by infiltration versus intravenous remifentanil injection in pediatric dentistry under general anesthesia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211123053154N2

Enrollment

Registered

2026-05-13

Start date

2026-06-10

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dental caries with pulp exposure. Dental caries

Interventions

Intervention 1: Intervention group: In the first group, remifentanil is used for pain control in doses of 10 mg. In this study, to facilitate accurate adjustment of the infusion pump, remifentanil sol

Eligibility

Sex/Gender

All

Age

4 Years to 7 Years

Inclusion criteria

Inclusion criteria: Healthy children (ASA health levels 1 and 2) aged 4 to 7 years who are referred for dental treatment under general anesthesia. There is a need to treat 5 to 8 posterior teeth. If permanent teeth need treatment, only restorative treatments or fissure sealants should be performed. The child must undergo pulpotomy treatment. Children whose dental treatment session lasts an average of two and a half hours.

Exclusion criteria

Exclusion criteria: Children whose parents or guardians do not sign a consent form to participate in the study. Children with a history of sensitivity or allergic reaction to local anesthetics.

Design outcomes

Primary

Measure	Time frame
Pain. Timepoint: Before the intervention, after the intervention during anesthesia, 1 hour after the end of anesthesia, 24 hours after the end of anesthesia. Method of measurement: Using an anesthesia machine, pulse oximetry, and a visual questionnaire.;Complications after anesthesia (Nausea, Vomiting, Agitation). Timepoint: Before the intervention, after the intervention during anesthesia, 1 hour after the end of anesthesia, 24 hours after the end of anesthesia. Method of measurement: Using an anesthesia machine, pulse oximetry, and a visual questionnaire.	—

Measure

Time frame

Pain. Timepoint: Before the intervention, after the intervention during anesthesia, 1 hour after the end of anesthesia, 24 hours after the end of anesthesia. Method of measurement: Using an anesthesia machine, pulse oximetry, and a visual questionnaire.;Complications after anesthesia (Nausea, Vomiting, Agitation). Timepoint: Before the intervention, after the intervention during anesthesia, 1 hour after the end of anesthesia, 24 hours after the end of anesthesia. Method of measurement: Using an anesthesia machine, pulse oximetry, and a visual questionnaire.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohamad Esmaeilzadeh

Shahid Beheshti University of Medical Sciences

dr.m.esmaeilzadeh@sbmu.ac.ir+98 21 2217 5350

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026