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The aim of this study is to compare the clinical efficacy and safety profiles of a 30 minutes acupuncture session performed at an ER of a tertiary hospital versus titrated intravenous morphine in the management of acute severe pain syndromes (defined as a visual analogue scale (VAS) score >/= 70) taking for example acute renal colic.
acupuncture session performed at an ER of a tertiary hospital versus titrated intravenous morphine in the management of acute severe pain syndromes (defined as a visual analogue scale (VAS) score >/= 70) taking for example acute renal colic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | Traditional Acupuncture Session:Patients in this group will benefit from a 30 minutes acupuncture session made by an experimented physician. |
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| Titrated Morphine | Active Comparator | Morphine Titration:Patients will receive an intravenous titration of morphine by a qualified nurse. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Acupuncture Session | Procedure | Skin disinfection was made by an antiseptic solution in the sites of insertion and sterile acupuncture needles were used (0.25 x 0.5 mm). Patients were installed in a seated position and needles were inserted perpendicularly through the skin to a depth of 1 - 2 cm until the "De Qi" was achieved. The "DeQi" corresponds to a feeling of numbness and tingling within the range of acupoint, The insertion sites are represented by the urinary bladder meridian points to the side of the pain (UB21, UB22, UB23, UB24, UB26, UB45, UB46, UB47, UB48 and UB49). |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score Change | Pain score is measured by a 100 millimeter visual analogue scale (VAS) and corresponds to the severity of the pain felt by the patient and varying from 0 (corresponding to no pain) to 100 (corresponding to the maximum imaginable pain). | at baseline and 10, 20, 30, 45 and 60 minutes after the start of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events | Corresponds to the occurence of side effects related to the intervention. Side effects occurence is evaluated via a checklist for each study group and the degree of amputability is evaluated via a 3 point likert scale (1: not probable, 2: probable and 3 : very probable / almost certain). In the morphine group we followed patients for the occurence of drowsiness, dizziness, nausea and vomiting, respiratory distress and hypotension. In the acupuncture group we followed patients for the occurence of local rush / bleeding / itching, needle blockage and fainting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nouira Semir, Professor | University Hospital of Monastir | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fattouma Bourguiba University Hospital | Monastir | Monastir Governorate | 5000 | Tunisia |
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| ID | Term |
|---|---|
| D056844 | Renal Colic |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Morphine Titration | Drug | Morphine was previously prepared by a study nurse by diluting a 10 mg / 1 ml flakon of morphine chlorhydrate in a 9 ml solution of serum saline to obtain a 10 ml preparation (1 ml = 1 mg). An initial bolus of 0.1 mg per Kg of actual body weight of morphine chlorhydrate solution is administered. A titration dose of 0.1 mg / Kg of body weight was repeated every 5 minutes' interval until reaching the therapeutic goal. |
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| during the 1 hour protocol and up to 2 hours after |