A Randomized, Double-blind Comparison of Morphine and Sufentanil for Prehospital Traumatic Severe Acute Pain

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00656773
First received: April 7, 2008
Last updated: February 25, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Acute Pain
Drug: Sufentanil
Drug: Morphine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Comparison of Morphine and Sufentanil for Treatment of Prehospital Traumatic Severe Acute Pain.

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 108
Study Start Date: January 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Sufentanil
0.15 μg/kg, IV following by 0.075 μg/kg every 3 minutes during 15 minutes
Active Comparator: 2 Drug: Morphine
0.15 mg/kg, IV following by 0.075 mg/kg every 3 minutes during 15 minutes

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656773

Locations
France
U H Toulouse Samu 31
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: DUCASSE Jean-louis, MD UH Toulouse
  More Information

No publications provided by University Hospital, Toulouse

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LLAU Marie-Elise, University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00656773     History of Changes
Other Study ID Numbers: 07 139 03, N° EUDRACT 2007-004049-14
Study First Received: April 7, 2008
Last Updated: February 25, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
morphine, sufentanil, acute pain, opioid, Prehospital Emergency Care

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Sufentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 28, 2014