Acupuncture Versus IV Morphine in the Treatment of Acute Pain in ED (AcuMoPE)
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|ClinicalTrials.gov Identifier: NCT02152410|
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : June 20, 2016
Renal colics are a common cause af acute intense pain in medical emergency settings requiring often the use of high level antalgics (opioid) to relief the patient.
In the other hand, Acupuncture is well known widely for its therapeutic characteristics, especially in relieving pain.
the aim of these study is to compare this two pain relieving techniques in patients consulting the emergency departement (ED) for acute onset renal colics.
|Condition or disease||Intervention/treatment||Phase|
|Renal Colic||Device: acupuncture Drug: Morphine||Early Phase 1|
acute onset pain is a frequent cause for consulting the ED (2/3 of patients). renal colics are a common cause for severe acute onset pain, we think approximatively 20% of patients consulting the ED for severe (VAS > 70) acute onset pain have renal colics (RC).
the guidelines for the treatment of severe RC recommend the association of two drugs: a nonsteroidal anti-inflammatory agent (NSAI) typically the Ketoprofen and an antalgic typically opioid (Morphine).
but this one face many critics regarding its safety and tolerance, that's why we investigated other pain relief strategies such as acupuncture.
acupuncture is one of the five branches of the traditional chinese medicine, it has proven its efficacity and safety in many conditions and in RC.
the aim of these study is to assess the feasibility, the safety, and the tolerance of an acupuncture pain-relief strategy compared to the conventional one (intravenous opioids) in the treatment of severe acute onset RC in emergency departement settings.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Two Antalgic Strategies: Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in Emergency Departement. A Randomized Trial of Efficacy and Safety|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2014|
Experimental: acupuncture group
The patient receives acupuncture session lasts between 20 to 30 minutes. Acupuncture will be applied according to the standards for reporting interventions in clinical trials of acupuncture (STRICTA).
Acupuncture will be applied according to the standards for reporting interventions in clinical trials of acupuncture (STRICTA)
Active Comparator: Morphine group
Each patient must receive a bolus of 5 mg of morphine (5 cc) and 2 mg (2cc) every 10 minutes if no improvement (VAS> 30).
bolus of 5 mg of morphine (5 cc) and 2 mg (2cc) every 10 minutes if no improvement of VAS (VAS> 30).
- pain relief by VAS [ Time Frame: at baseline, 10, 20, 30, 45 and 60 minutes ]
the primary outcome is to assess the efficacity of acupuncture versus IV morphine expressed in VAS reduction during treatment.
if there is a reduction of more than 50% of the baseline VAS, than the treatment is considered efficient.
- side effects [ Time Frame: during the 60 minutes of the treatment ]
during the 60 minutes of the treatment, we checked the patient for side effects:
- for morphine: rush, nausea, vomiting, dizziness, dyspnea...
- for acupuncture: needle fracture, needle retention, muscular contractions... if there are no major side effects noted (vomiting, severe dizziness, allergic reaction, needle fracture) the treatment is considered safe.
- number of patients completing the treatment [ Time Frame: at baseline ]we calculated the number of patients that accepted the acupuncture treatment versus patient with conventional treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152410
|university of Monastir|
|Monastir, Non-US/Canada, Tunisia, 5000|
|Fattouma Bourguiba University Hospital|
|Monastir, Tunisia, 5000|
|Principal Investigator:||Nouira Samir, Professor||University hospital of Monastir|