Effectiveness of New Analgesic Strategy Compared to the Usal Antalgic Strategy - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00874172

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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: sickle cell disease

MedlinePlus related topics: Anemia Sickle Cell Anemia

Drug Information available for: Acetaminophen CT 2584 Nitrous oxide

U.S. FDA Resources

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 ]

Estimated Enrollment:	200
Study Start Date:	June 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator 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
1: Experimental 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

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 néfopam administration: hypersensitivity to néfopam, 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, 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874172

Contacts

Contact: Aline SANTIN, MD

(0)1 49 81 49 52 ext +33

aline.santin@hmn.aphp.fr

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:	Department Research and development ( Amel Ouslimani )
Study ID Numbers:	P070605, OST07010
Study First Received:	April 1, 2009
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00874172 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Anemia
Sickle Cell
Analgesic

Pain
Emergency treatment
Quality of life

Study placed in the following topic categories:

Morphine
Hematologic Diseases
Nitrous Oxide
Anemia
Central Nervous System Depressants
Anesthetics
Anemia, Hemolytic
Quality of Life
Pain
Nefopam
Anesthetics, Inhalation
Anemia, Hemolytic, Congenital

Genetic Diseases, Inborn
Anesthetics, General
Analgesics, Non-Narcotic
Hemoglobinopathies
Emergencies
Sickle Cell Anemia
Peripheral Nervous System Agents
Analgesics
Hemoglobinopathy
Anemia, Sickle Cell
Acetaminophen

Additional relevant MeSH terms:

Hematologic Diseases
Nitrous Oxide
Physiological Effects of Drugs
Anemia
Central Nervous System Depressants
Anesthetics
Anemia, Hemolytic
Pharmacologic Actions
Anesthetics, Inhalation
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn

Anesthetics, General
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Hemoglobinopathies
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anemia, Sickle Cell
Acetaminophen

ClinicalTrials.gov processed this record on September 11, 2009