Studying the Effect of Pain-Relief Medicines Given Before Treatment on Pain During and After Root Canal in Children’s Back Teeth

Phase 4

Not yet recruiting

• Conditions: Other and unspecified diseases ofpulp and periapical tissues,

• Registration Number: CTRI/2025/06/088998
• Lead Sponsor: Somya Seth

Brief Summary

This randomized clinical trial aims to evaluate the effectiveness of preoperative analgesics in reducing pain during and after pulpectomy procedures in children aged 4 to 9 years. The study will compare three groups: one receiving ibugesic , another receiving paracetamol , and a third receiving a placebo (Vitamin B-complex). The primary objective is to determine whether administering analgesics before treatment can improve pain control at various stages of the procedure. Pain levels will be assessed at five key time points: during local anesthesia injection, during the procedure, and at 1 hour, 4 hours, and 6 hours following the treatment. The results of this study may contribute to improved pain management strategies in pediatric dental practice, enhancing the comfort and overall experience for young patients undergoing pulpectomy.

**Study Hypothesis:** Children who receive ibugesic or paracetamol before a pulpectomy will report lower levels of postoperative pain compared to those who receive a placebo.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-16
• Study Start: 2025-06-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1.Children aged 4 to 9 years.
• 2.Children who need pulpectomy in mandibular primary molar 3.Children who are healthy (ASA I or II).
• 4.Children who can understand and follow simple instructions.
• 5.Children having Frankl Behaviour rating scale of 3 or 4.
• 6.Children whose parents or guardians give written consent to take part in the study.

Exclusion Criteria

• 1.Children who have allergies to any pain medication (like ibuprofen or paracetamol).
• 2.Children who are already taking painkillers or antibiotics before the treatment.
• 3.Children with acute infections, facial swelling, or abscess near the tooth.
• 4.Children with serious medical problems (e.g., heart conditions, kidney or liver disease).
• 5.Children with special healthcare needs or behavioral issues that may affect treatment.
• 6.Children who have received pulpectomy treatment in the same tooth earlier.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in postoperative pain following primary molar pulpectomy in children.	1.During local anaesthesia injection. | 2.During the procedure | 3.1 hour post procedure | 4.4 hours post procedure | 5.6 hours post procedure

Trial Locations

Locations (1)

Saveetha Dental College And Hospitals; 🇮🇳 Thiruvallur, TAMIL NADU, India

Saveetha Dental College And Hospitals

🇮🇳Thiruvallur, TAMIL NADU, India

Dr Somya Seth

Principal investigator

7597698819

sdc.ssomya@gmail.com