Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in the Emergency Department

NCT02460913 | Completed Phase 2

• 1 other identifier: 13/02
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Inadequate pain management is a common problem encountered in ED settings. Pain relief medications use is often limited by their side effects. Evidence suggests that non pharmacologic pain relief techniques such as acupuncture can play a central role to treat pain in acute conditions, but their application is still scarce.

Conditions

Acute Pain

Keywords

acupuncture; morphine; acute pain

Outcome Measures

Primary Outcomes (1)

• change of pain severity from baseline

  Change of pain score was assessed at 10, 20, 30, 45 and 60 minutes time points from the starting of the protocol. Pain severity was measured using the visual analogic scale (VAS) going from 10 (maximum imaginable pain) to 0 (no pain). if the VAS was not applicable to certain patients, a verbal numeric rating scale (NRS) was used instead. Success of treatment was defined by a drop in the pain intensity under 30.

  10, 20, 30, 45, 60 minutes

Secondary Outcomes (2)

• resolution time

  10, 20, 30, 45, 60 minutes

• adverse events

  10, 20, 30, 45, 60 minutes and until ED discharge

Study Arms (2)

Acupuncture

EXPERIMENTAL

patients received a 20 to 30 minutes session of acupuncture

Procedure: Acupuncture

IV Morphine

ACTIVE COMPARATOR

patients received an intravenous titration of morphine every 5 minutes.

Drug: Morphine titration

Interventions

Acupuncture PROCEDURE

Acupuncture session of 20 to 30 minutes. Treatment protocols were determined through review of major clinical manuals and textbooks, literature review, and a panel of specialist acupuncturists from Chinese medicine backgrounds.

Acupuncture

Morphine titration DRUG

Patients in this group received IV titrated morphine. Morphine was prepared onsite and diluted in a manner to obtain a dose of 1mg in each ml of normal saline. The initial dose was 0.1 mg per kg and a titration dose of 0.05 mg per Kg was repeated every 5 minutes until reaching objective. The maximum allowed dose was 1.5 mg/kg.

Also known as: Morphine

IV Morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute onset pain \< 72 hours of the ED presentation
• Pain intensity ≥ 40 of the VAS or NRS (ranging from 0 for no pain to 100 for maximum imaginable pain)
• Acute musculoskeletal pain with no evidence of fracture or dislocation, including ankle and knee sprains without signs of severity (ligament rupture, laxity), shoulder and elbow tendinitis, upper and lower limb mechanical pains and lower back pain with no evidence of neurological deficit.
• Acute abdominal pain with no urging surgical intervention including renal colic and dysmenorrhea.
• Acute headache that meets the criteria of primary headache, as described by the international headache society.

You may not qualify if:

• Temperature \> 37.7°c
• Violent mechanism of trauma
• Patients under anticoagulant drugs or with coagulation abnormalities
• Skin affections (infections, hematoma, dermatosis) that would impair the use of certain acupuncture points
• Patients that were judged enable to participate in the study at the discretion of the treating physician.
• Refusal, inability to consent.
• Inability to assess the degree of pain using the VAS or NRS
• Patients who had received analgesics in the 6 hours prior to the enrollment
• An initial pain score ≤ 40 on the VAS or NRS
• Patients who had presented to the ED in the last 24 hours with the same motif
• Pregnancy

Sponsors & Collaborators

• University of Monastir: lead

Related Publications (2)

• Kim KH, Lee BR, Ryu JH, Choi TY, Yang GY. The role of acupuncture in emergency department settings: a systematic review. Complement Ther Med. 2013 Feb;21(1):65-72. doi: 10.1016/j.ctim.2012.12.004. Epub 2012 Dec 29.

  PMID: 23374207 BACKGROUND

• Cohen M, Parker S, Taylor D, Smit de V, Ben-Meir M, Cameron P, Xue C. Acupuncture as analgesia for low back pain, ankle sprain and migraine in emergency departments: study protocol for a randomized controlled trial. Trials. 2011 Nov 15;12:241. doi: 10.1186/1745-6215-12-241.

  PMID: 22085683 BACKGROUND

MeSH Terms

Conditions

Acute Pain

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 semir, MD

  University of Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2015
• First Posted: June 3, 2015
• Study Start: April 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 21, 2020

Record last verified: 2020-02