A Randomized, Double-blind Comparison of Morphine and Sufentanil for Prehospital Traumatic Severe Acute Pain
Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
Participant gender:
Summary
Obtaining high-quality analgesia in prehospital patients with severe pain is an important
treatment objective for medical team. Opioids are recognized as the treatment of choice for
relief of severe acute pain. Recommended initial analgesia of patients with severe acute
pain, defined as a visual analog scale or a numerical rating scale (NRS) score of 60/100 or
higher, in a prehospital setting in France consists of the administration of opioids by the
medical staff of mobile intensive care units. The intravenous administration of morphine is
usually considered as the gold standard for postoperative acute pain relief because of its
rapid transport from the blood to target tissues after intravenous injection, its
long-lasting analgesic effect without any plateau, and its well-known pharmacokinetics.
Nevertheless, the short-acting opioid sufentanil might be preferable to the traditional
long-acting morphine for prehospital analgesia because of its even faster onset of action and
shorter duration than morphine. There is no study, to our knowledge, comparing the clinical
efficacy of sufentanil vs morphine in a prehospital setting. This randomized double-blind
group clinical trial is designed to determine the best intravenous opioid titration protocol
by comparing sufentanil and morphine for medical prehospital treatment of adult patients with
severe acute pain. Eligible patients with a numerical rating scale (NRS) score of 60/100 or
higher will be randomly allocated to receive either 0.15 µg/kg sufentanil then 0.075 µg/kg
every 3 minutes (group A) or 0.15 mg/kg morphine then 0.075 mg/kg every 3 minutes (group B)
intravenously. The decision to provide opioid analgesia including titration of subsequent
doses of narcotic is the responsibility of physicians and intravenous analgesia will be given
and titrated according to the pain score every 3 minutes. The drugs will be administered by
the physician from syringes of similar appearance prepared by the nurse who is not otherwise
involved in the study. The protocol-defined primary outcome measure is the percentage of
patients with pain relief (with a NRS score of 30/100 or lower) 15 minutes after the first
injection. Secondary outcomes include pain score comparisons every 3 minutes within the first
30 minutes and comparison of adverse events. The physician blinded to the analgesic treatment
groups will do all assessments of patients. The safety evaluation will include non invasive
monitoring of blood pressure, heart rate, respiratory rate, oxygen saturation by pulse
oximetry (Spo2), and a sedation scale (0, patient is awake; 1, patient is with intermittent
sleeping; 2, patient is sleeping, awakened by verbal stimulation; 3, patient is sleeping,
awakened by tactile stimulation; 4, patient is not aroused by stimulation) at these periods.
Fifteen minutes after the first injection, overall patient and investigator satisfaction with
analgesia was recorded.