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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 March 2015 |
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Main ID: |
NCT02187614 |
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Date of registration:
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07/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy Study of Different Analgesic Options in Kidney Stone Pain Management
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Scientific title:
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A Double Blind, Multi-arm Randomized Control Trial, for Efficacy of Intramuscular Diclofenac Versus Intravenous Morphine Versus Intravenous Paracetamol, in Renal Colic Emergency Department Pain Management |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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1645 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02187614 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Qatar
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Contacts
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Name:
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Prof. Peter A Cameron, MD,FACEM |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hamad Medical Corporation |
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Name:
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Dr.Sameer A. Pathan, MBBS, MCEM |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hamad Medical Corporation |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age >=18 years and < 65 years
- Acute onset, one side flank or loin pain, with or without radiation to groin or
genital areas.
- Pain intensity on NRS more than or equal to 4. (Moderate to Severe Pain)
- Diagnosis confirmed by non contrast CT KUB within the ED visit.
Exclusion Criteria:
- Traumatic flank pain
- Pregnancy
- Known renal failure or impairment
- Known allergy to morphine, diclofenac or paracetamol
- Bronchial asthma
- Previously enrolled in the study.
- Use of any analgesia in last 6 hour.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Urinary Calculi
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Renal Colic
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Intervention(s)
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Drug: Paracetamol
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Drug: Morphine
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Drug: Placebos
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Drug: Diclofenac
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Primary Outcome(s)
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The proportion of patients achieving a reduction of >50% on Numerical Rating Scale (NRS-11) from the initial NRS recorded at the end of 30 minutes in each study arm.
[Time Frame: at 30 minutes after analgesia]
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Secondary Outcome(s)
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reduction in mean NRS
[Time Frame: at 30, 60 and 90 minutes after analgesia]
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Secondary ID(s)
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Hamad Medical Corporation-MRC
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IRB Number: 14-00059
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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