Clinical Trial Comparing Intravenous and Oral Diclofenac and Pharmacokinetics

• Status: Unknown status
• Trial end date: 2018-04-15
• Target enrollment: 0
• Participant gender: All

Summary

NSAIDs are commonly used in the management of acute pain; Diclofenac is one from the same class. It is an amino phenyl acetic acid derivative which inhibits prostaglandin biosynthesis to produce analgesic, antipyretic and anti-inflammatory effect. The drug efficacy and safety in acute pain management has been proved by several studies like in renal colic, post and pre-operative pain management, migraines etc. It's also known to have an opioid-sparing effect. Mode of administration is one of the important factors to consider in a busy emergency room. Perception about the route of administration differs among patients. As believed,injectable have rapid onset, easier to titrate, and patients respond better to them as they consider them stronger than oral medication. Number of trials has compared oral and parenteral NSAIDs. Most found no benefit to the parenteral route. Considering the limitations of the previously done studies like small sample size, heterogeneity in the group of patients enrolled, improper blinding and comparing of two different drugs from the same class. Therefore, aim of the study is to conduct a Double blind randomized clinical trial to assess the clinical efficacy and pharmacokinetic parameters of oral diclofenac compared to intramuscular diclofenac in patients with acute limb injury.

In this two group double blind randomized clinical trial, the clinical efficacy and pharmacokinetic parameters among the two groups will be assessed. Eligible patients visiting to HGH-ED, age (above 18 years) with acute limb injury, having moderate to severe pain (defined as pain score of >=4 on Numerical rating scale) will be recruited. With the use of computer generated block randomization, subjects will be allocated to one of the two treatment groups in the ratio of 1:1. Each group will receive either (intramuscular diclofenac / oral placebo) or (oral diclofenac / intramuscular placebo). Among the 300 subjects enrolled for the study, further stratified randomization will be done in order to enroll 20 patients for pharmacokinetic study within the subjects.High-performance liquid chromatography, method will be used for the determination of drug concentration in human plasma, for detailed pharmacokinetics. The pain score will be assessed by using the validated pain scale i.e. Numerical rating scale (NRS). The participants, clinicians and investigators will be masked to treatment assigned and the results will be analyzed by the intention to treat analysis among the two group treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hamad Medical Corporation
• Treatments: Diclofenac

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