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

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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sickle Cell Anemia	Drug: Rapid optimized analgesic strategy; Drug: current analgesic strategy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: October 2009
• Actual Primary Completion Date: October 2012
• Actual Study Completion Date: November 2012

Arms and Interventions

Arm	Intervention/treatment
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
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

Outcome Measures

Primary Outcome Measures :

1. Rate of pain relief (Numeric Pain Intensity Scale < 4) [ Time Frame: at 30 min after admission to the ED ]

Secondary Outcome Measures :

1. Overall amount of morphine delivered [ Time Frame: during the first 4 hours of ED presentation ]
2. Overall amount of morphine delivered [ Time Frame: during the hospital stay following ED presentation and enrolment in the study ]
3. Analgesic drugs related adverse events [ Time Frame: during the hospital stay following ED presentation and enrolment in the study ]
4. Length of hospital stay [ Time Frame: during the hospital stay ]
5. 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. ]
6. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes 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

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

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT00874172
• Other Study ID Numbers: P070605-OST07010
• First Posted: April 2, 2009
• Last Update Posted: December 18, 2012
• Last Verified: November 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Anemia; Sickle Cell; Analgesic; Pain; Emergency treatment; Quality of life

Additional relevant MeSH terms:

Anemia, Sickle Cell; Anemia; Hematologic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Genetic Diseases, Inborn; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs