Effectiveness of New Analgesic Strategy Compared to the Usal Antalgic Strategy

NCT00874172 | Completed DMC

• 1 other identifier: P070605-OST07010
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Anemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of pain relief (Numeric Pain Intensity Scale < 4)

  at 30 min after admission to the ED

Secondary Outcomes (6)

• 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.

Study Arms (2)

2

ACTIVE COMPARATOR

Combination of acetaminophen, morphine

Drug: current analgesic strategy

1

EXPERIMENTAL

Combination of acetaminophen, nitrous oxide, nefopam, morphine

Drug: Rapid optimized analgesic strategy

Interventions

Rapid optimized analgesic strategy 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

1

current analgesic strategy DRUG

paracetamol 1 g per os nasal oxygen therapy 1 amp of morphine 10 mg / 10 cc of glucose 5 %, by repeated bolus administration

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• female adult patient
• complicated sickle cell crisis or admission requirement to an ICU
• recent hospitalisation (\< 10 days) for the same complaint
• contraindication to anyone of the study drugs
• no medical insurance
• incompetent adult

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital, Emergency Department

Créteil, 94000, France

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Anemia; Pain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aline SANTIN, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 18, 2012

Record last verified: 2012-11

Locations

FR (1)