Comparison of the safety and efficacy of a morphine-alfentanil mixture versus morphine alone for the management of severe pain in the Emergency Department

Phase 4

Recruiting

• Conditions: Pain (with a pain severity score rated at greater than or equal to seven out of ten) arising from any cause; Anaesthesiology - Pain management

• Registration Number: ACTRN12611000829910
• Lead Sponsor: Dr. Adrianne Boonstra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Patients aged 18 to 70 years (inclusive) with a pain score of greater than or equal to 7.
-Body weight > 50 kg
-patients able to communicate well with the study staff and comply with the study requirements and the study restrictions.
-patients able to understand the Patient Information Sheet and provide a written consent to take part in the study as well as to have a good understanding of the procedure and a good command of English.

Exclusion Criteria

-younger than 18 years of age and older than 70 years.
-with known allergies or intolerance, or contradictions to the use of alfentanil, fentanyl or morphine.
-with severe cardiac or respiratory disease (American Society of Anesthesiologists class 4-5),.
-who are opioid tolerant.
-with a history or evidence of drug abuse (including opioids, alcohol, cocaine, benzodiazepines and cannabis), opioid dependence and currently in acute (short lasting) opioid withdrawal.
-who are taking opioid antagonists e.g. naltrexone.
-who are unable to effectively communicate pain using verbal pain scores.
-who have significant cognitive impairment or CNS disturbance.
-who are currently using regularly CNS depressants
-who are taking irreversible monoamine oxidase inhibitors (MAOIs)
-renal impairment (known calculated creatinine clearance of < 75ml/min
-with liver function tests (transaminases) greater than double the normal range.
-who are pregnant or lactating females

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the time taken to achieve comfort, which has been defined as a pain score of less than or equal to four out of ten.[The primary timepoint is once the patient has achieved comfort.]

Secondary Outcome Measures

Name	Time	Method
A secondary outcome is the safety of the trial drug (alfentanil-morphine combination) as compared to standard treatment (morphine alone.) This will be measured by comparing the number of adverse events (nausea, vomiting, pruritis, allergic reaction and opiate toxicity.) The adverse effects will be based on a bedside assessment by the treating doctor and patient reporting of adverse effects. The presence or absence of adverse effect will be recorded on a data sheet.[Adverse effects will be monitored for throughout the duration of the study.]