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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00874172
Other study ID # P070605-OST07010
Secondary ID
Status Completed
Phase N/A
First received April 1, 2009
Last updated December 17, 2012
Start date October 2009
Est. completion date November 2012

Study information

Verified date November 2012
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 176
Est. completion date November 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
France Henri Mondor Hospital, Emergency Department Créteil

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of pain relief (Numeric Pain Intensity Scale < 4) at 30 min after admission to the ED No
Secondary Overall amount of morphine delivered during the first 4 hours of ED presentation No
Secondary Overall amount of morphine delivered during the hospital stay following ED presentation and enrolment in the study No
Secondary Analgesic drugs related adverse events during the hospital stay following ED presentation and enrolment in the study Yes
Secondary Length of hospital stay during the hospital stay No
Secondary 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. No
Secondary measurement of oxygen saturation in tissue (amendment n°1 - 14/09/2009) measurement of oxygen saturation in tissue in 4hours after admission to the emergency No
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