Pain Management Clinical Trial
Official 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
Verified date | March 2018 |
Source | Hamad Medical Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | April 15, 2018 |
Est. primary completion date | April 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Qatar | Isma Qureshi | Doha |
Lead Sponsor | Collaborator |
---|---|
Hamad Medical Corporation |
Qatar,
Derry P, Derry S, Moore RA, McQuay HJ. Single dose oral diclofenac for acute postoperative pain in adults. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD004768. doi: 10.1002/14651858.CD004768.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;7:CD004768. — View Citation
Gan TJ, Daniels SE, Singla N, Hamilton DA, Carr DB. A novel injectable formulation of diclofenac compared with intravenous ketorolac or placebo for acute moderate-to-severe pain after abdominal or pelvic surgery: a multicenter, double-blind, randomized, multiple-dose study. Anesth Analg. 2012 Nov;115(5):1212-20. doi: 10.1213/ANE.0b013e3182691bf9. Epub 2012 Aug 10. — View Citation
Marret E, Kurdi O, Zufferey P, Bonnet F. Effects of nonsteroidal antiinflammatory drugs on patient-controlled analgesia morphine side effects: meta-analysis of randomized controlled trials. Anesthesiology. 2005 Jun;102(6):1249-60. — View Citation
Pathan SA, Mitra B, Straney LD, Afzal MS, Anjum S, Shukla D, Morley K, Al Hilli SA, Al Rumaihi K, Thomas SH, Cameron PA. Delivering safe and effective analgesia for management of renal colic in the emergency department: a double-blind, multigroup, randomised controlled trial. Lancet. 2016 May 14;387(10032):1999-2007. doi: 10.1016/S0140-6736(16)00652-8. Epub 2016 Mar 16. — View Citation
Turturro MA, Paris PM, Seaberg DC. Intramuscular ketorolac versus oral ibuprofen in acute musculoskeletal pain. Ann Emerg Med. 1995 Aug;26(2):117-20. — View Citation
Uçar R, Biyik M, Uçar E, Polat I, Çifçi S, Ataseven H, Demir A. Rectal or intramuscular diclofenac reduces the incidence of pancreatitis afterendoscopic retrograde cholangiopancreatography. Turk J Med Sci. 2016 Jun 23;46(4):1059-63. doi: 10.3906/sag-1502-104. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in proportion of patients achieving 50% pain reduction | The primary outcome is defined as the proportion of patients achieving pain reduction by 50% at 30 minutes following analgesia administration. | 30 mins | |
Primary | the mean difference in plasma concentration for two drugs | Cmax - Peak plasma concentration and Time curve | 60 mins | |
Secondary | 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 | to assess proportion of patients who could achieve minimal significant pain reduction | at 30 mins | |
Secondary | Rescue analgesia | proportion of patients requiring a rescue analgesia after 30 min in each group | after 30 mins | |
Secondary | Adverse events | the number of adverse events in each group | 2 hours |
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