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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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27 June 2016 |
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Main ID: |
NCT02781415 |
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Date of registration:
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16/05/2016 |
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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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Acupuncture Versus Titrated Morphine in Patients With Renal Colic
AcuRC |
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Scientific title:
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Comparison of Acupuncture and Titrated (TM) Morphine in Patients Presenting to the Emergency Room (ER) With Acute Renal Colic (RC) |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02781415 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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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 Hospital of Monastir |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age > 18 years old
- Presenting with acute non complicated renal colic
- Baseline VAS score >/= 70
Exclusion Criteria:
- complicated renal colic
- VAS score < 70
- Pain of traumatic origin
- Coagulation abnormalities
- Skin affections impairing the use of pre-specified insertion points
- Enable to use the VAS
- Patients who received analgesics less than 6 hours prior to enrollment
- Patients refusing or enable to give written informed consent
- Pregnant women
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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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: Morphine Titration
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Procedure: Traditional Acupuncture Session
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Primary Outcome(s)
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Pain score Change
[Time Frame: at baseline and 10, 20, 30, 45 and 60 minutes after the start of intervention]
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Secondary Outcome(s)
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Number of participants with treatment-related adverse events
[Time Frame: during the 1 hour protocol and up to 2 hours after]
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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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