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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/11/007437
• Date of registration: 04-11-2016
• Prospective Registration: Yes
• Primary sponsor: Sir Takhtsinhaji General Hospital and Government Medical College Bhavnagar
• Public title: A study to see the analgesic and safety efficacy of Tab. Diclofenac sodium and Tab. Etodolac
• Scientific title: 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
• Date of first enrolment: 14-11-2016
• Target sample size: 100
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=15606
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Double Blind Double Dummy
• Phase: Phase 4

Countries of recruitment

India

Contacts

• Name: Dr CB Tripathi
• Affiliation: Government Medical College Bhavnagar

• Name: Dr CB Tripathi
• Affiliation: Government Medical College Bhavnagar

Key inclusion & exclusion 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: 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.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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.

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

NIL

Source(s) of Monetary Support

Department of Pharmacology Government Medical COllege and Sir Takhtasinhji general hospital jail road Bhavnagar

Ethics review

Status: Approved
Approval date: 23/05/2016
Contact:

Institutional Ethics Committee, Government Medical College, Bhavnagar