Effectiveness of New Analgesic Strategy Compared to the Usal Antalgic Strategy (DREPANOX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00874172
First received: April 1, 2009
Last updated: December 17, 2012
Last verified: November 2012
  Purpose

Quality of life of adult patients with sickle cell disease is deeply impaired by severe adverse medical events that inadvertently occur throughout their time life. Indeed, patients not presenting a life threatening condition often present to the emergency department with sickle cell disease crisis related pain. Currently, the effectiveness of specific analgesic strategies for treating sickle cell disease crisis related pain are mostly based on acetaminophen and opioid derivates combination along with oxygen delivery. Those strategies are effective but may last up to half an hour to obtain pain relief. This delay mostly depends on the availability of venous access and on individual patient response to treatment. Nitrous oxide is a volatile efficient analgesic therapy that has been repeatedly shown to allow rapid analgesia in the emergency department setting.

The investigators hypothesise that a new analgesic strategy (rapid optimized analgesic strategy) including nitrous oxide and nefopam would be as safe and more rapidly effective than current analgesic strategy.


Condition Intervention
Sickle Cell Anemia
Drug: Rapid optimized analgesic strategy
Drug: current analgesic strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: New Analgesic Strategy Combining Nitrous Oxide, Nefopam, Acetaminophen and Morphine Compared to the Usal Antalgic Strategy (Acetaminophen and Morphine) for the Treatment of Acute Sickle Cell Disease Pain in the Emergency Room

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Rate of pain relief (Numeric Pain Intensity Scale < 4) [ Time Frame: at 30 min after admission to the ED ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall amount of morphine delivered [ Time Frame: during the first 4 hours of ED presentation ] [ Designated as safety issue: No ]
  • Overall amount of morphine delivered [ Time Frame: during the hospital stay following ED presentation and enrolment in the study ] [ Designated as safety issue: No ]
  • Analgesic drugs related adverse events [ Time Frame: during the hospital stay following ED presentation and enrolment in the study ] [ Designated as safety issue: Yes ]
  • Length of hospital stay [ Time Frame: during the hospital stay ] [ Designated as safety issue: No ]
  • Overall number of sickle cell crisis and patients'quality of life (EuroQol-EQ 5D, SF-36) and patients' satisfaction regarding pain management (pain management satisfaction questionnaire) [ Time Frame: at 7 days and 30 days of follow-up. ] [ Designated as safety issue: No ]
  • measurement of oxygen saturation in tissue (amendment n°1 - 14/09/2009) [ Time Frame: in 4hours after admission to the emergency ] [ Designated as safety issue: No ]
    measurement of oxygen saturation in tissue


Enrollment: 176
Study Start Date: October 2009
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Combination of acetaminophen, morphine
Drug: current analgesic strategy

paracetamol 1 g per os nasal oxygen therapy

1 amp of morphine 10 mg / 10 cc of glucose 5 %, by repeated bolus administration

Other Name: current analgesic strategy
Experimental: 1
Combination of acetaminophen, nitrous oxide, nefopam, morphine
Drug: Rapid optimized analgesic strategy

Oral treatment :

1 gr Acetaminophen 20 mg of nefopam delivered on a lump sugar Nitrous oxide inhalation with initial output of 9 L/min subsequently Intravenous morphine bolus of 3 mg Nitrous oxide interruption after 5 minutes of the initial morphine bolus

Other Name: Rapid optimized analgesic strategy

Detailed Description:

Purpose of the study:

The main objective is to evaluate the effectiveness of an optimized combination of analgesic therapies for treating uncomplicated sickle cell disease crisis at initial visit to the emergency room of the Henri Mondor hospital.

Secondary objectives:

  • Total amount of morphine required during the first 4 hours in the hospital emergency.
  • Overall amount of morphine administered on the duration of patient stay in hospital Henri Mondor.
  • Side effects of analgesic strategies
  • Adverse medical events
  • Length of hospital stay.
  • 7-day and 1-month follow-up and collection of following data:

    1. Total number of sickle cell disease crises
    2. Number of subsequent readmission and/or visit to an ED
    3. Quality of life (EuroQol EQ-5D, and SF-36)
    4. Patient satisfaction: pain treatment satisfaction scale. Study design: prospective monocentric open-label randomized controlled trial Number of patients: 200 Follow up per patient: 1 month, Study enrolment period: 25 months.

Contraindications to nefopam administration: hypersensitivity to nefopam, benign prostatic hypertrophy and glaucoma, or history of seizures.

  • contraindication to morphine administration hypersensitivity to morphine, decompensate respiratory failure, acute head trauma, uncontrolled epilepsy, severe hepatocellular failure, intracranial hypertension, use of buprenorphine or nalbuphine Contraindications to MEOPA administration, intra-cranial hypertension, non cooperative patient (sleepiness; encephalopathy, refusal to participate), pneumothorax, emphysema, pneumoperitoneum, digestive occlusion, pneumomediastinum, air embolism, diving accident , facial trauma, patients who recent administration of an ophthalmic gas (SF6, C3F8, C2F6) < 3 months).
  • contraindication to the use of oxygen: no-absolute contraindication no health insurance, adults under tutelage

Main criterion:

Proportion of patients relieved (pain intensity by simple numerical scale <4) to 30 minutes of their arrival in the emergency department.

Secondary criteria:

  • amount of morphine administrated within the first 4 hours of presentation to the emergency department
  • overall amount of morphine administrated during hospital stay
  • adverse event related with study treatment
  • adverse medical events during hospitalization
  • length of stay.
  • 7-day and 1-month follow-up to collect the following data:

    1. Total number of sickle cell disease crises
    2. Number of subsequent readmission and/or visit to an ED
    3. Quality of life (EuroQol EQ-5D, and SF-36)
    4. Patient satisfaction: pain treatment satisfaction scale.
  Eligibility

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

Inclusion Criteria:

  • male adult patient with sickle cell anemia,
  • age ≥ 18 years,
  • main complaint : sickle cell crisis pain,
  • initial numeric pain intensity scale at presentation > 4,
  • admission to the ED during working hours (amendment n°2-15/02/2010:from 8h to 20h), from Monday to Friday

Exclusion Criteria:

  • female adult patient
  • complicated sickle cell crisis or admission requirement to an ICU
  • recent hospitalisation (< 10 days) for the same complaint
  • previous inclusion in the study
  • contraindication to anyone of the study drugs
  • no medical insurance
  • incompetent adult
  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: NCT00874172

Locations
France
Henri Mondor Hospital, Emergency Department
Créteil, France, 94000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Aline SANTIN, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00874172     History of Changes
Other Study ID Numbers: P070605-OST07010
Study First Received: April 1, 2009
Last Updated: December 17, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Anemia
Sickle Cell
Analgesic
Pain
Emergency treatment
Quality of life

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Acetaminophen
Nitrous Oxide
Analgesics
Morphine
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Narcotics
Anesthetics, Inhalation
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on July 22, 2014