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

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ClinicalTrials.gov Identifier: NCT00874172
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : December 18, 2012
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE April 1, 2009
First Posted Date  ICMJE April 2, 2009
Last Update Posted Date December 18, 2012
Study Start Date  ICMJE October 2009
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
Rate of pain relief (Numeric Pain Intensity Scale < 4) [ Time Frame: at 30 min after admission to the ED ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00874172 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2010)
  • Overall amount of morphine delivered [ Time Frame: during the first 4 hours of ED presentation ]
  • Overall amount of morphine delivered [ Time Frame: during the hospital stay following ED presentation and enrolment in the study ]
  • Analgesic drugs related adverse events [ Time Frame: during the hospital stay following ED presentation and enrolment in the study ]
  • Length of hospital stay [ Time Frame: during the hospital stay ]
  • 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. ]
  • measurement of oxygen saturation in tissue (amendment n°1 - 14/09/2009) [ Time Frame: in 4hours after admission to the emergency ]
    measurement of oxygen saturation in tissue
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
  • Overall amount of morphine delivered [ Time Frame: during the first 4 hours of ED presentation ]
  • Overall amount of morphine delivered [ Time Frame: during the hospital stay following ED presentation and enrolment in the study ]
  • Analgesic drugs related adverse events [ Time Frame: during the hospital stay following ED presentation and enrolment in the study ]
  • Length of hospital stay [ Time Frame: during the hospital stay ]
  • 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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of New Analgesic Strategy Compared to the Usal Antalgic Strategy
Official Title  ICMJE 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
Brief Summary

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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Anemia
Intervention  ICMJE
  • 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

  • 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

Study Arms  ICMJE
  • Active Comparator: 2
    Combination of acetaminophen, morphine
    Intervention: Drug: current analgesic strategy
  • Experimental: 1
    Combination of acetaminophen, nitrous oxide, nefopam, morphine
    Intervention: Drug: Rapid optimized analgesic strategy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2012)
176
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2009)
200
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00874172
Other Study ID Numbers  ICMJE P070605-OST07010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aline SANTIN, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP