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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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12 December 2020 |
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Main ID: |
NCT02156596 |
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Date of registration:
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03/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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IV NSAI Versus Nebulized Morphine Analgesia for First-line Renal Colic
NSAIvsNM |
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Scientific title:
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Intravenous Treatment With Non Steroidal Anti Inflammatory Drugs (NSAID) Versus Nebulized Morphine (NM) Analgesia for First-line Renal Colic: Randomized Controlled Double-blind Single-center Study. |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02156596 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
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Phase:
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Phase 1
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Countries of recruitment
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Tunisia
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Contacts
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Name:
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Nouira Semir, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Monastir |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Over 16 years old
- Consenting to participate in the study
- Diagnosis of renal colic matching flank pain / lumbar fossa sided with dipstick and /
or imaging confirmed the diagnosis
- VAS> 50% at consultation
Exclusion Criteria:
- Inability to assess pain VAS;
- Pregnant or lactating woman;
- Recognized renal disease (glomerular filtration rate <60ml/kg/1.73m2);
- Known hepatic insufficiency;
- Known or suspected allergy to NSAIDs, morphine
- Peptic ulcer known;
Age minimum:
16 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Renal Colic
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Intervention(s)
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Drug: IV NSAI
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Drug: NM
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Drug: Nebulised Serum Saline
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Drug: IV Serum Saline
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Primary Outcome(s)
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efficacity: VAS pain reduction
[Time Frame: 5, 15, 30, 45 and 60 minutes]
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Secondary Outcome(s)
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feasibility of the study: number of patients accepting the adhesion to protocol
[Time Frame: at base line and at 60 minutes]
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safety: side effects of treatment
[Time Frame: 5, 15, 30, 45 and 60 minutes]
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Secondary ID(s)
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NSAI vs Morphine
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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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