Acupuncture Versus IV Morphine in the Treatment of Acute Pain in ED (AcuMoPE)
Primary Purpose
Renal Colic
Status
Completed
Phase
Early Phase 1
Locations
Tunisia
Study Type
Interventional
Intervention
acupuncture
Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Renal Colic focused on measuring acupuncture, renal colic
Eligibility Criteria
Inclusion Criteria:
age over 18 years
- has a renal colic
- VAS over 70
- has not got another analgesic drug before coming to emergency departement
Exclusion Criteria:
age under 18 years
- has not renal colic
- VAS under 70
- has got another analgesic treatment before coming to emergency departement
- fever (T° > 38.5°c)
- cutaneous infection in the punction sites
- anuric patient
- contre indication of morphine
Sites / Locations
- university of Monastir
- Fattouma Bourguiba University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
acupuncture group
Morphine group
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
pain relief by VAS
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.
Secondary Outcome Measures
side effects
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
we calculated the number of patients that accepted the acupuncture treatment versus patient with conventional treatment
Full Information
NCT ID
NCT02152410
First Posted
September 11, 2013
Last Updated
June 17, 2016
Sponsor
University of Monastir
Collaborators
Emergency NGO Onlus
1. Study Identification
Unique Protocol Identification Number
NCT02152410
Brief Title
Acupuncture Versus IV Morphine in the Treatment of Acute Pain in ED
Acronym
AcuMoPE
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 Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir
Collaborators
Emergency NGO Onlus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic
Keywords
acupuncture, renal colic
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
acupuncture group
Arm Type
Experimental
Arm Description
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).
Arm Title
Morphine group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
acupuncture
Intervention Description
Acupuncture will be applied according to the standards for reporting interventions in clinical trials of acupuncture (STRICTA)
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
bolus of 5 mg of morphine (5 cc) and 2 mg (2cc) every 10 minutes if no improvement of VAS (VAS> 30).
Primary Outcome Measure Information:
Title
pain relief by VAS
Description
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.
Time Frame
at baseline, 10, 20, 30, 45 and 60 minutes
Secondary Outcome Measure Information:
Title
side effects
Description
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.
Time Frame
during the 60 minutes of the treatment
Title
number of patients completing the treatment
Description
we calculated the number of patients that accepted the acupuncture treatment versus patient with conventional treatment
Time Frame
at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age over 18 years
has a renal colic
VAS over 70
has not got another analgesic drug before coming to emergency departement
Exclusion Criteria:
age under 18 years
has not renal colic
VAS under 70
has got another analgesic treatment before coming to emergency departement
fever (T° > 38.5°c)
cutaneous infection in the punction sites
anuric patient
contre indication of morphine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nouira Samir, Professor
Organizational Affiliation
University hospital of Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
university of Monastir
City
Monastir
State/Province
Non-US/Canada
ZIP/Postal Code
5000
Country
Tunisia
Facility Name
Fattouma Bourguiba University Hospital
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
1729516
Citation
Lee YH, Lee WC, Chen MT, Huang JK, Chung C, Chang LS. Acupuncture in the treatment of renal colic. J Urol. 1992 Jan;147(1):16-8. doi: 10.1016/s0022-5347(17)37121-5.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/23213979
Description
Acupuncture has a good analgesic effect with a low incidence of adverse reactions.
Learn more about this trial
Acupuncture Versus IV Morphine in the Treatment of Acute Pain in ED
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