Acupuncture Versus IV Morphine in the Treatment of Acute Pain in ED

NCT02152410 | Completed Early Phase 1 DMC

• 1 other identifier: 48003/12
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Renal Colic

Keywords

acupuncture; renal colic

Outcome Measures

Primary Outcomes (1)

• 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.

  at baseline, 10, 20, 30, 45 and 60 minutes

Secondary Outcomes (2)

• side effects

  during the 60 minutes of the treatment

• number of patients completing the treatment

  at baseline

Study Arms (2)

acupuncture group

EXPERIMENTAL

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).

Device: acupuncture

Morphine group

ACTIVE COMPARATOR

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).

Drug: Morphine

Interventions

acupuncture DEVICE

Acupuncture will be applied according to the standards for reporting interventions in clinical trials of acupuncture (STRICTA)

acupuncture group

Morphine DRUG

bolus of 5 mg of morphine (5 cc) and 2 mg (2cc) every 10 minutes if no improvement of VAS (VAS\> 30).

Morphine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18 years
• has a renal colic
• VAS over 70
• has not got another analgesic drug before coming to emergency departement

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead
• Emergency NGO Onlus: collaborator

Study Sites (2)

Fattouma Bourguiba University Hospital

Monastir, Monastir Governorate, 5000, Tunisia

Location

university of Monastir

Monastir, Non-US/Canada, 5000, Tunisia

Location

Related Publications (1)

• 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.

  PMID: 1729516 RESULT

Related Links

• Acupuncture has a good analgesic effect with a low incidence of adverse reactions.

MeSH Terms

Conditions

Renal Colic

Interventions

Acupuncture Therapy; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Nouira Samir, Professor

  University hospital of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: June 2, 2014
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2014
• Last Updated: June 20, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

TU (2)