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Effect of warm or cold anesthetic on pain and stress in 5- to 7-year-old children during dental injection

Investigating the effect of anesthetic temperature on pain and anxiety caused by inferior alveolar nerve block injection in children aged 5 to 7 years referring to Sari Dental School: A double-blind, split-mouth randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20260503069251N1
Enrollment
36
Registered
2026-05-27
Start date
2026-08-27
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 visit anxiety.

Interventions

Intervention group: Injection of 2% lidocaine with epinephrine 1:80000 at 37°C (body temperature) for inferior alveolar nerve block. Injection duration: over 60 seconds using a 27-gauge needle..

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 7 Years

Inclusion criteria

Inclusion criteria: Children aged 5 to 7 years ASA I health status (healthy children) Signed written informed consent by parents/legal guardians Children with positive or definitely positive behavior on the Frankl Behavior Rating Scale Need for inferior alveolar nerve block injection on both right and left sides (bilateral primary mandibular molars requiring pulp treatment)

Exclusion criteria

Exclusion criteria: Use of non-steroidal anti-inflammatory drugs (NSAIDs) within 12 hours prior to the study Lack of cooperation by the child during the procedure Presence of infection at the injection site Hypersensitivity or allergy to local anesthetics, cold sensitivity, underlying vascular or immunological diseases Previous unsuccessful dental treatment experience

Design outcomes

Primary

MeasureTime frame
Pain score measured immediately after inferior alveolar nerve block injection using Wong-Baker Faces Pain Rating Scale and 10-cm Visual Analogue Scale (VAS). Timepoint: Immediately after injection. Method of measurement: Wong-Baker Faces Pain Rating Scale and 10-cm Visual Analogue Scale (VAS).

Secondary

MeasureTime frame
1. Heart rate measured as beats per minute2. Respiratory rate measured as breaths per minute3. Systolic blood pressure in mmHg4. Diastolic blood pressure in mmHg. Timepoint: Before and immediately after injection. Method of measurement: 1. Stethoscope2. Manual counting3. Digital sphygmomanometer4. Digital sphygmomanometer.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHoorieh Abedi

Mazandaran University of Medical Sciences

drhoorieabedi@gmail.com+98 11 3310 8823

Outcome results

None listed

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