Clinical Trial Comparing Intravenous and Oral Diclofenac and Pharmacokinetics
Status:
Unknown status
Trial end date:
2018-04-15
Target enrollment:
Participant gender:
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.