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

Assessing Impact of Preoperative Analgesics on Interoperative And Postoperative Pain in Pediatric Patients Undergoing Primary Molar Pulpectomy : A Randomised Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088998
Enrollment
60
Registered
2025-06-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: K049- Other and unspecified diseases ofpulp and periapical tissues

Interventions

Intervention1: Ibugesic (Ibuprofen + Paracetamol)(tablet) 1.Ibugesic 200mg 2.Ibugesic 400mg: Administered orally as a single dose 30 minutes prior to the dental procedure. Dosage calculated based on b

Sponsors

Somya Seth
Lead Sponsor

Eligibility

Inclusion criteria

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

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. 7.Children whose tooth is indicated for extraction (e.g., due to severe decay, mobility).

Design outcomes

Primary

MeasureTime frame
Reduction in postoperative pain following primary molar pulpectomy in children.Timepoint: 1.During local anaesthesia injection. 2.During the procedure 3.1 hour post procedure 4.4 hours post procedure 5.6 hours post procedure

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDinesh Kumar B

Saveetha Dental College and Hospitals

dineshkumarb.sdc@saveetha.com9952007702

Outcome results

None listed

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