Sickle Cell AnemiaDREPANOXNCT00874172
Effectiveness of New Analgesic Strategy Compared to the Usal Antalgic Strategy
A study testing Rapid optimized analgesic strategy and current analgesic strategy in people with Sickle Cell Anemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Sickle Cell Anemia
- What is being tested?
- Rapid optimized analgesic strategy and current analgesic strategy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Sickle Cell Anemia
- Being tested
- Rapid optimized analgesic strategy, current analgesic strategy
- Keywords
- Anemia, Sickle Cell, Analgesic, Pain, Emergency treatment, Quality of life
- Medical subject headings
- Anemia, Sickle Cell, Anemia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid optimized analgesic strategyDrug
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 strategyDrug
paracetamol 1 g per os nasal oxygen therapy
1 amp of morphine 10 mg / 10 cc of glucose 5 %, by repeated bolus administration
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Combination of acetaminophen, morphine Receives: Drug: current analgesic strategy |
| 1 | Experimental | Combination of acetaminophen, nitrous oxide, nefopam, morphine Receives: Drug: Rapid optimized analgesic strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pain relief (Numeric Pain Intensity Scale < 4)
Measured: at 30 min after admission to the ED
Secondary outcomes (6)
Overall amount of morphine delivered
Measured: during the first 4 hours of ED presentation
Overall amount of morphine delivered
Measured: during the hospital stay following ED presentation and enrolment in the study
Analgesic drugs related adverse events
Measured: during the hospital stay following ED presentation and enrolment in the study
Length of hospital stay
Measured: 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)
Measured: at 7 days and 30 days of follow-up.
measurement of oxygen saturation in tissue (amendment n°1 - 14/09/2009)
measurement of oxygen saturation in tissue
Measured: in 4hours after admission to the emergency
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aline SANTIN, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874172
- Sponsor's protocol ID
- P070605-OST07010
- Acronym
- DREPANOX
- Status last verified
- Nov 2012
- First submitted
- 1 Apr 2009
- Last updated
- 18 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00874172
- Acronym / sponsor ID
- DREPANOX / P070605-OST07010
- Conditions
- Sickle Cell Anemia
- Keywords
- Anemia, Sickle Cell, Analgesic, Pain, Emergency treatment, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: current analgesic strategyCombination of acetaminophen, morphine |
| 1 | Experimental | Drug: Rapid optimized analgesic strategyCombination of acetaminophen, nitrous oxide, nefopam, morphine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid optimized analgesic strategyOral 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 | Drug | 1 |
| current analgesic strategyparacetamol 1 g per os nasal oxygen therapy 1 amp of morphine 10 mg / 10 cc of glucose 5 %, by repeated bolus administration | Drug | 2 |
Primary outcome
Rate of pain relief (Numeric Pain Intensity Scale < 4)
Time frame: at 30 min after admission to the ED
6 secondary outcomes
Overall amount of morphine delivered
Time frame: during the first 4 hours of ED presentation
Overall amount of morphine delivered
Time frame: during the hospital stay following ED presentation and enrolment in the study
Analgesic drugs related adverse events
Time frame: during the hospital stay following ED presentation and enrolment in the study
Length of hospital stay
Time frame: 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)
Time frame: at 7 days and 30 days of follow-up.
measurement of oxygen saturation in tissue (amendment n°1 - 14/09/2009)
Time frame: in 4hours after admission to the emergency
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aline SANTIN, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid optimized analgesic strategy and current analgesic strategy in people with Sickle Cell Anemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of pain relief (Numeric Pain Intensity Scale < 4) (time frame: at 30 min after admission to the ED). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2012.