Sickle Cell DiseasePHEDRENCT02580565
Prevalence of Problematic Use of Equimolar Mixture of Oxygen and Nitrous Oxide and Analgesics in the Sickle-cell Disease
An observational study of Sickle Cell Disease, run by Nantes University Hospital at 1 site in France.
Trial summary
The use of analgesics can lead to cases of drug abuse and dependence. It can also cause pseudo-addiction in patients suffering from pain. What is the actual situation in patients suffering from severe sickle-cell disease, exposed to acute pain during vaso-occlusive crises? Evaluation of the use of analgesics, on the… Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- telephone interview
- How many people
- 1,004 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2015to 31 Dec 2017
- Phase
- Observational
- 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 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: French sickle-cell disease population who has a problematic use of Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) and analgesics
Who may be able to join
- Subject with confirmed SCD diagnosis, regardless whether it is the homozygous or heterozygous form
- Subject treated for SCD at a RSCCA participating in the study, regardless of the duration of the illness
- Subject under the age of 26
- Written consent from adult subjects and written consent from one of the parents or legal guardians of minors
Who cannot join
- State-protected adult (under guardianship)
- Subject not having the general aptitude to participate in the study assessment (i.e. not able to respond to the telephone interview): too young, insufficient motor development, major difficulties understanding the French language and/or speech and/or hearing disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PHEDRE Trial Protocol - Observational Study of the Prevalence of Problematic Use of Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) and Analgesics in the French Sickle-cell Disease Population
The use of analgesics can lead to cases of drug abuse and dependence. It can also cause pseudo-addiction in patients suffering from pain. What is the actual situation in patients suffering from severe sickle-cell disease, exposed to acute pain during vaso-occlusive crises? Evaluation of the use of analgesics, on the basis of Diagnostic and Statistical Manual of Mental Disorders criteria for substance abuse and dependence, makes it possible to differentiate the symptoms occurring only in a context of pain, in the aim of managing the pain, and thus describing pseudo-addiction, from symptoms also occurring when there is no pain, and more in favour of true addiction. Currently there is no data available in France on this problem, and no studies have been carried out in children or adolescents with sickle-cell disease. The purpose of the study is to evaluate the prevalence of problematic use of equimolar mixture of oxygen and nitrous oxide and other analgesic drugs in a population of subjects with severe sickle-cell disease in France.
PHEDRE (Pharmacodépendance Et DREpanocytose-drug dependence and sickle-cell disease) is an observational, descriptive and transversal study. Patients under the age of 26 with sickle-cell disease are included in the study by the doctors looking after them in sickle-cell disease centres. The patients are then contacted by a trained researcher for a telephone interview, including an evaluation of the Diagnostic and Statistical Manual of Mental Disorders criteria for abuse and dependence to equimolar mixture of oxygen and nitrous oxide and for each of the analgesic drugs taken by the patient. The data are also completed using the subject's medical record.
This study will make it possible to provide an initial quantitative and qualitative evaluation of problematic use of equimolar mixture of oxygen and nitrous oxide and analgesic drugs in the sickle-cell disease population. The results will be used firstly to provide additional data essential for monitoring the risk of overdose, abuse, dependence and misuse of these products, and to begin awareness-raising and to provide information for health care professionals, in order to significantly improve the management of sickle-cell disease-related pain.
Read the detailed description
This is a national multicentric observational study
•Clinical assessment
After he includes a patient, the medical practitioner complete a clinical assessment which contains all information about patient's family and personal history, history of the SCD and treatment already received for SCD. The clinical assessment is kept in the Reference Centre or Special Centre for Children and Adults (RSCCA). Therefore, the trained researcher will schedule a visit to the RSCCA to retrieve the clinical assessments of all patients included in this RSCCA and enter the data in the electronic case report form (e-CRF).
- Telephone interview
Telephone interview is carried out with a trained researcher from Nantes CEIP-A. When Nantes CEIP-A receipts the inclusion form and written consent, the trained researcher schedules a telephone interview with the patient. The interview is suited to the child's, adolescent's or young adult's age, maturity and comprehension skills. The following parameters are evaluated during the telephone semi-structured interview for EMONO, and for other analgesic drugs, during pain episodes and outside pain episodes.
- Conditions
- Sickle Cell Disease
- Being tested
- telephone interview
- Keywords
- sickle cell disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone interviewOther
Clinical assessment for screening and a phone call for questionnaire administration
What is being measured
The primary outcome is the main question the study is designed to answer.
Problematic use is abuse of or dependence on a substance according to the fourth edition of DSM (DSM-IV), and substance use disorder according to the fifth edition (DSM 5).
The primary outcome mesure is evaluation of problematic use of EMONO. The DSM (Diagnostic and Satistical Manual) identifies 11 criteria for problematic use. The presence or absence of each criteria is assessed by phone with the patient. Therefore, the total number of criteria is calculated for each patient and represents the severity of problematic use.
Measured: 24 months after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study start25 Sep 2015
- Primary completion25 Sep 2016
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Marseille, University Hospital, Clermont-Ferrand, University Hospital, Toulouse, University Hospital, Paris, University Hospital, Lille
- Responsible party
- Sponsor
- Investigators
- Marie GERARDIN, Doctor, Principal investigator, Hospital practitioner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580565
- Sponsor's protocol ID
- RC14_0344
- Acronym
- PHEDRE
- Status last verified
- May 2018
- First submitted
- 28 Sep 2015
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Gerardin M, Rousselet M, Couec ML, Masseau A; PHEDRE Group; Aquizerate A, Authier N, Deheul S, Roussin A, Micallef J, Djezzar S; French Addictovigilance Network (FAN); Feuillet F, Jolliet P, Grall-Bronnec M, Victorri-Vigneau C. Substance use disorder of equimolar oxygen-nitrous oxide mixture in French sickle-cell patients: results of the PHEDRE study. Orphanet J Rare Dis. 2024 Mar 18;19(1):124. doi: 10.1186/s13023-024-03133-w.
PubMed 38500184Gerardin M, Rousselet M, Couec ML, Masseau A, Guerlais M, Authier N, Deheul S, Roussin A, Micallef J, Djezzar S; French Addictovigilance Network (FAN); Feuillet F, Jolliet P, Victorri-Vigneau C. Descriptive analysis of sickle cell patients living in France: The PHEDRE cross-sectional study. PLoS One. 2021 Mar 18;16(3):e0248649. doi: 10.1371/journal.pone.0248649. eCollection 2021.
PubMed 33735176Gerardin M, Couec ML, Grall-Bronnec M, Feuillet F, Wainstein L, Rousselet M, Pinot ML, Perrouin F, Bonnot O, Drouineau MH, Jolliet P, Victorri-Vigneau C. PHEDRE trial protocol - observational study of the prevalence of problematic use of Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) and analgesics in the French sickle-cell disease population. BMC Psychiatry. 2015 Nov 14;15:281. doi: 10.1186/s12888-015-0677-5.
PubMed 26573686
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHEDRE Trial Protocol - Observational Study of the Prevalence of Problematic Use of Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) and Analgesics in the French Sickle-cell Disease Population
- ClinicalTrials.gov ID
- NCT02580565
- Acronym / sponsor ID
- PHEDRE / RC14_0344
- Conditions
- Sickle Cell Disease
- Keywords
- sickle cell disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Marseille, University Hospital, Clermont-Ferrand, University Hospital, Toulouse, University Hospital, Paris, University Hospital, Lille
- Study start
- 25 Sep 2015 (actual)
- Primary completion
- 25 Sep 2016 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 20 Oct 2015 (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.
The use of analgesics can lead to cases of drug abuse and dependence. It can also cause pseudo-addiction in patients suffering from pain. What is the actual situation in patients suffering from severe sickle-cell disease, exposed to acute pain during vaso-occlusive crises? Evaluation of the use of analgesics, on the basis of Diagnostic and Statistical Manual of Mental Disorders criteria for substance abuse and dependence, makes it possible to differentiate the symptoms occurring only in a context of pain, in the aim of managing the pain, and thus describing pseudo-addiction, from symptoms also occurring when there is no pain, and more in favour of true addiction. Currently there is no data available in France on this problem, and no studies have been carried out in children or adolescents with sickle-cell disease. The purpose of the study is to evaluate the prevalence of problematic use of equimolar mixture of oxygen and nitrous oxide and other analgesic drugs in a population of subjects with severe sickle-cell disease in France.
PHEDRE (Pharmacodépendance Et DREpanocytose-drug dependence and sickle-cell disease) is an observational, descriptive and transversal study. Patients under the age of 26 with sickle-cell disease are included in the study by the doctors looking after them in sickle-cell disease centres. The patients are then contacted by a trained researcher for a telephone interview, including an evaluation of the Diagnostic and Statistical Manual of Mental Disorders criteria for abuse and dependence to equimolar mixture of oxygen and nitrous oxide and for each of the analgesic drugs taken by the patient. The data are also completed using the subject's medical record.
This study will make it possible to provide an initial quantitative and qualitative evaluation of problematic use of equimolar mixture of oxygen and nitrous oxide and analgesic drugs in the sickle-cell disease population. The results will be used firstly to provide additional data essential for monitoring the risk of overdose, abuse, dependence and misuse of these products, and to begin awareness-raising and to provide information for health care professionals, in order to significantly improve the management of sickle-cell disease-related pain.
Detailed description
This is a national multicentric observational study
•Clinical assessment
After he includes a patient, the medical practitioner complete a clinical assessment which contains all information about patient's family and personal history, history of the SCD and treatment already received for SCD. The clinical assessment is kept in the Reference Centre or Special Centre for Children and Adults (RSCCA). Therefore, the trained researcher will schedule a visit to the RSCCA to retrieve the clinical assessments of all patients included in this RSCCA and enter the data in the electronic case report form (e-CRF).
- Telephone interview
Telephone interview is carried out with a trained researcher from Nantes CEIP-A. When Nantes CEIP-A receipts the inclusion form and written consent, the trained researcher schedules a telephone interview with the patient. The interview is suited to the child's, adolescent's or young adult's age, maturity and comprehension skills. The following parameters are evaluated during the telephone semi-structured interview for EMONO, and for other analgesic drugs, during pain episodes and outside pain episodes.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- French sickle-cell disease population who has a problematic use of Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) and analgesics
Key inclusion criteria (4 listed)
- Subject with confirmed SCD diagnosis, regardless whether it is the homozygous or heterozygous form
- Subject treated for SCD at a RSCCA participating in the study, regardless of the duration of the illness
- Subject under the age of 26
- Written consent from adult subjects and written consent from one of the parents or legal guardians of minors
Key exclusion criteria (2 listed)
- State-protected adult (under guardianship)
- Subject not having the general aptitude to participate in the study assessment (i.e. not able to respond to the telephone interview): too young, insufficient motor development, major difficulties understanding the French language and/or speech and/or hearing disorders
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 |
|---|---|---|
| telephone interviewClinical assessment for screening and a phone call for questionnaire administration | Other | – |
Primary outcome
Problematic use is abuse of or dependence on a substance according to the fourth edition of DSM (DSM-IV), and substance use disorder according to the fifth edition (DSM 5).
Time frame: 24 months after the start of the study
The primary outcome mesure is evaluation of problematic use of EMONO. The DSM (Diagnostic and Satistical Manual) identifies 11 criteria for problematic use. The presence or absence of each criteria is assessed by phone with the patient. Therefore, the total number of criteria is calculated for each patient and represents the severity of problematic use.
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 24 Jun 2026.
- Derived from this study: PubMed 38500184Gerardin M, Rousselet M, Couec ML, Masseau A; PHEDRE Group; Aquizerate A, Authier N, Deheul S, Roussin A, Micallef J, Djezzar S; French Addictovigilance Network (FAN); Feuillet F, Jolliet P, Grall-Bronnec M, Victorri-Vigneau C. Substance use disorder of equimolar oxygen-nitrous oxide mixture in French sickle-cell patients: results of the PHEDRE study. Orphanet J Rare Dis. 2024 Mar 18;19(1):124. doi: 10.1186/s13023-024-03133-w.
- Derived from this study: PubMed 33735176Gerardin M, Rousselet M, Couec ML, Masseau A, Guerlais M, Authier N, Deheul S, Roussin A, Micallef J, Djezzar S; French Addictovigilance Network (FAN); Feuillet F, Jolliet P, Victorri-Vigneau C. Descriptive analysis of sickle cell patients living in France: The PHEDRE cross-sectional study. PLoS One. 2021 Mar 18;16(3):e0248649. doi: 10.1371/journal.pone.0248649. eCollection 2021.
- Derived from this study: PubMed 26573686Gerardin M, Couec ML, Grall-Bronnec M, Feuillet F, Wainstein L, Rousselet M, Pinot ML, Perrouin F, Bonnot O, Drouineau MH, Jolliet P, Victorri-Vigneau C. PHEDRE trial protocol - observational study of the prevalence of problematic use of Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) and analgesics in the French sickle-cell disease population. BMC Psychiatry. 2015 Nov 14;15:281. doi: 10.1186/s12888-015-0677-5.
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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.
Marie GERARDIN, Doctor principal investigator
Hospital practitioner
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Nantes University Hospital 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 4 inclusion and 2 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 24 Jun 2026. 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?
Problematic use is abuse of or dependence on a substance according to the fourth edition of DSM (DSM-IV), and substance use disorder according to the fifth edition (DSM 5). (time frame: 24 months after the start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02580565, which also lists 3 linked publications.
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 24 Jun 2026.