Effectiveness of New Analgesic Strategy Compared to the Usal Antalgic Strategy

NCT ID: NCT00874172

Last Updated: 2012-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-11-30

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.

Conditions

Sickle Cell Anemia

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2

Combination of acetaminophen, morphine

Group Type: ACTIVE_COMPARATOR

current analgesic strategy

Intervention Type: DRUG

paracetamol 1 g per os nasal oxygen therapy

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

1

Combination of acetaminophen, nitrous oxide, nefopam, morphine

Group Type: EXPERIMENTAL

Rapid optimized analgesic strategy

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aline SANTIN, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Henri Mondor Hospital, Emergency Department

Créteil, , France

Countries

France

Other Identifiers

P070605-OST07010

Identifier Type: -

Identifier Source: org_study_id