RecruitingPhase 4ACTRN12611000829910

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

In emergency department patients at Lyell McEwin Hospital is a morphine-alfentanil mixture more effective than morphine alone in reducing pain scores

Sponsor

Dr. Adrianne Boonstra

Enrollment

330 participants

Start Date

May 30, 2011

Study Type

Interventional

Conditions

Pain (with a pain severity score rated at greater than or equal to seven out of ten) arising from any cause

Summary

This study will compare the safety and efficacy of morphine-alfentanil mixture with morphine alone for the treatment of severe pain in the emergency department at the Lyell McEwin Hospital. Alfentanil is a short acting opiate with rapid onset, where morphine is a longer acting opiate which is slower in its onset of action. It has previously been shown, in post-surgical patients, that a mixture of alfentanil and morphine can safely reduce the time to comfort when compared with morphine alone. We hypothesize that within the emergency department, the alfentanil-morphine mixture will safely reduce the time to effective analgesia.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria4

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 Criteria13

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

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Interventions

Patients with acute pain with pain scores greater than or equal to 7 will be administered analgesia according to a standard protocol, either receiving the trial medication (a mixture of morphine and alfentanil) or the comparator, morphine alone. The morphine-alfentanil mixture will be in premixed syringes containing 50mcg of alfentanil and 0.75 mg of morphine per millilitre. Patients will be administered bolus doses of one to four millilitres at no less than three minutely intervals until their pain is adequately controlled, provided they do not experience adverse effects or need to be withdrawn from the trial.

Locations(1)

Australia

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ACTRN12611000829910