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A study to see the analgesic and safety efficacy of Tab. Diclofenac sodium and Tab. Etodolac

Comparison of Safety and Analgesic efficacy of Diclofenac sodium with Etodolac after Surgical removal of Third Molar Tooth randomized double blind double dummy parallel group study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/11/007437
Enrollment
100
Registered
2016-11-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patient with surgical removal of third molar tooth

Interventions

Intervention1: Tab. Etodolac: 400 mg Three times a day for 3 days. Control Intervention1: Tab. Diclofenac: 50 mg three times a day for three days.

Sponsors

Sir Takhtsinhaji General Hospital and Government Medical College Bhavnagar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Duration of acute pain less than 4 hours Participant willing to give written informed consent 2.Participants with impacted mandibular third molar tooth

Exclusion criteria

Exclusion criteria: 1.Participants with a history of sensitivity to any drugs. 2.Participants with injury to teeth. 3.Participants with acute pain more than 4 hours. 4.Participant with history of Valvular Heart Disease; Bypass surgery within 6 months; on anticoagulant drugs. 5.Pregnant or lactating women. 6.Participants who were unable to continue for the proposed length of treatment or return for follow-up visits. 7.Participant not willing to give written informed consent. 8.Participants with an uncontrolled Diabetes, Hypertension, Neoplasm. 9.Participant with known neuropsychiatric illness. 10.Participants with blood dyscrasia or coagulation disorders. 11.Participants having consumption of drugs of abuse or taken pain medication in the previous 24 hours.

Design outcomes

Primary

MeasureTime frame
Compare safety and analgesic efficacy of Diclofenac sodium with Etodolac after surgical removal of third molar tooth in terms of Visual Analogue Scale.Timepoint: 0,2,6,24,48,72 hours

Secondary

MeasureTime frame
The mean time to onset of analgesia, Time to maximum pain relief, Total pain relief and Summed Pain Intensity Difference. ï?? The degree of pain relief, Global evaluation (PGE: excellent, very good, good, fair, or poor) Timepoint: 0,2,6,24,48,72 hours

Countries

India

Contacts

Public ContactDr CB Tripathi

Government Medical College Bhavnagar

cbrtripathi@yahoo.co.in09825951678

Outcome results

None listed

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