- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00656773
A Randomized, Double-blind Comparison of Morphine and Sufentanil for Prehospital Traumatic Severe Acute Pain
May 10, 2017 updated by: University Hospital, Toulouse
A Randomized, Double-blind Comparison of Morphine and Sufentanil for Treatment of Prehospital Traumatic Severe Acute Pain.
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.
Study Overview
Detailed Description
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, controlled, double-blind, parallel group clinical trial is then 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 (pain relief classified as excellent, good, mild, or weak) was recorded.
We will analyze the primary and secondary end points using the intention-to-treat method.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Toulouse, France, 31059
- U H Toulouse Samu 31
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients aged 18 years or older
- with a severe traumatic acute pain defined by an NRS score of 60/100 or higher at randomization.
Exclusion Criteria:
- Patient-reported history of chronic respiratory, renal, or hepatic insufficiency
- known opioid or acetaminophen allergies
- treatment of chronic pain or treatment with opioids
- incapacity to understand the NRS
- hypotension (defined as a systolic blood pressure b90 mm Hg,bradypnea of less than 12/min, oxygen desaturation of less than 90%, seizures or a Glasgow Coma Scale score of less than 14
- pregnancy
- drug addiction
- Patients who had already received an analgesic, including aspirin or acetaminophen within 6 hours (either by self-administration or by another physician in attendance)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
0.15 μg/kg, IV following by 0.075 μg/kg every 3 minutes during 15 minutes
|
Active Comparator: 2
|
0.15 mg/kg, IV following by 0.075 mg/kg every 3 minutes during 15 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 15 minutes after the first injection.
|
15 minutes after the first injection.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Secondary outcomes include pain score comparisons every 3 minutes within the first 30 minutes, comparison of adverse events and overall patient and investigator satisfaction with analgesia.
Time Frame: 30 minutes
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: DUCASSE Jean-louis, MD, Uh Toulouse
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
April 7, 2008
First Submitted That Met QC Criteria
April 7, 2008
First Posted (Estimate)
April 11, 2008
Study Record Updates
Last Update Posted (Actual)
May 12, 2017
Last Update Submitted That Met QC Criteria
May 10, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Acute Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Morphine
- Sufentanil
Other Study ID Numbers
- 07 139 03
- N° EUDRACT 2007-004049-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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