Clinical Trial Comparing Intravenous and Oral Diclofenac and Pharmacokinetics

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03472339
• Date of registration: 01/03/2018
• Prospective Registration: No
• Primary sponsor: Hamad Medical Corporation
• Public title: Clinical Trial Comparing Intravenous and Oral Diclofenac and Pharmacokinetics
• Scientific title: A Randomized Double-blinded Trial Comparing the Clinical Efficacy and Pharmacokinetic Parameters of Oral Diclofenac and Intramuscular Diclofenac in Patients With Acute Limb Injuries
• Date of first enrolment: January 15, 2018
• Target sample size: 300
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT03472339
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Qatar

Contacts

• Name: Isma Qureshi

Key inclusion & exclusion criteria

Eligible patients are those adults (age at least 18years), presenting to HGH-ED with
complaints of acute limb injury, initially evaluated by the physician.

Inclusion criteria:

1. Healthy volunteers

2. Adult patients above 18-65 years of age.

3. Patients with soft tissue injury/ cut wounds

4. Pain score more than or equal to 4 on NRS.

5. Patients weight more than or equal to 50kgs.

6. If treating physician approves patient participation in the study.

7. Not on any medication.

Exclusion criteria:

1. Received any analgesic within last 12 hours, on the day of visit to ED.

2. Patients with fractures

3. Allergic to diclofenac.

4. Cardio-vascular disease, renal impairment, stroke or any other co-morbidity / chronic
illness.

5. Pregnancy / Nursing

6. Peptic ulcers

7. Bleeding disorders

8. liver disease

9. Bronchial asthma



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pain Management

Limb Injury

Intervention(s)

Drug: Diclofenac Sodium

Primary Outcome(s)

Difference in proportion of patients achieving 50% pain reduction [Time Frame: 30 mins]

the mean difference in plasma concentration for two drugs [Time Frame: 60 mins]

Secondary Outcome(s)

Adverse events [Time Frame: 2 hours]

Rescue analgesia [Time Frame: after 30 mins]

proportion of patients achieving pain reduction of >=2 Numerical Rating Scale( which is a numeric scale where respondent selects a whole number from 0 to 10, where 0 means no pain and 10 means worst pain) from the initial score [Time Frame: at 30 mins]

Secondary ID(s)

16413/16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors