DREPANOX: Effectiveness of New Analgesic Strategy Compared to the Usal Antalgic Strategy

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00874172

Collaborator

(none)

176

Enrollment

Location

Arms

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

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	N/A

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:

Total number of sickle cell disease crises
Number of subsequent readmission and/or visit to an ED
Quality of life (EuroQol EQ-5D, and SF-36)
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:

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

Study Design

Study Type:

Interventional

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 :

Oct 1, 2009

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Nov 1, 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

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

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

Secondary Outcome Measures

Overall amount of morphine delivered [during the first 4 hours of ED presentation]
Overall amount of morphine delivered [during the hospital stay following ED presentation and enrolment in the study]
Analgesic drugs related adverse events [during the hospital stay following ED presentation and enrolment in the study]
Length of hospital stay [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) [at 7 days and 30 days of follow-up.]
measurement of oxygen saturation in tissue (amendment n°1 - 14/09/2009) [in 4hours after admission to the emergency]
measurement of oxygen saturation in tissue

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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