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

Gérardin, Marie; Couec, Marie‐Laure; Grall‐Bronnec, Marie; Feuillet, Fanny; Wainstein, Laura; Rousselet, Morgane; Pinot, Marie-Lyne; Perrouin, Fanny; Bonnot, Olivier; Drouineau, Marie-Hélène; Jolliet, Pascale; Victorri-Vigneau, Caroline

doi:10.1186/s12888-015-0677-5

Cited by 5 publications

(5 citation statements)

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“…The PHEDRE study protocol was previously described in a publication, freely available online [ 22 ]. It was a national, observational, and transversal study based on an interview carried out by the Nantes Addictovigilance Centre and funded by a Grant from the French National Agency for Medicines and Health Products Safety (Agence Nationale de Sécurité du Médicament et des produits de santé – ANSM).…”

Section: Methodsmentioning

confidence: 99%

Substance use disorder of equimolar oxygen-nitrous oxide mixture in French sickle-cell patients: results of the PHEDRE study

Gérardin,

Rousselet,

Couec

et al. 2024

Orphanet J Rare Dis

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Background In many countries, nitrous oxide is used in a gas mixture (EMONO) for short-term analgesia. Cases of addiction, with significant misuse, have been reported in hospitalized patients. Patients suffering from sickle cell disease (SCD) could represent a high-risk population for substance use disorder (SUD) due to their significant pain crisis and repeated use of EMONO. The objective of the PHEDRE study was to assess the prevalence of SUD for EMONO in French SCD patients. Results A total of 993 patients were included. Among 339 EMONO consumers, only 38 (11%) had a SUD, with very few criteria, corresponding mainly to a mild SUD due to a use higher than expected (in quantity or duration) and relational tensions with the care teams. Almost all patients (99.7%) were looking for an analgesic effect, but 68% of patients were also looking for other effects. The independent risks factors associated with at least one SUD criterion were: the feeling of effects different from the expected therapeutic effects of EMONO, at least one hospitalization for vaso occlusive crisis in the past 12 months and the presence of a SUD for at least one other analgesic drug. Conclusions The use of EMONO was not problematic for the majority of patients. Manifestations of SUD that led to tensions with healthcare teams should alert and lead to an evaluation, to distinguish a true addiction from a pseudoaddiction which may be linked to an insufficient analgesic treatment related to an underestimation of pain in SCD patients. Trial registration: Clinical Trials, NCT02580565. Registered 16 October 2015, https://clinicaltrials.gov/

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Section: Methodsmentioning

confidence: 99%

Substance use disorder of equimolar oxygen-nitrous oxide mixture in French sickle-cell patients: results of the PHEDRE study

Gérardin,

Rousselet,

Couec

et al. 2024

Orphanet J Rare Dis

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“…The PHEDRE study was a national observational, transversal, cross-sectional study conducted by the Nantes pharmacology addictovigilance department [ 21 ]. It was monitored by a pluri-disciplinary steering committee comprising pharmacologists, psychiatrists specialised in addiction, biostatisticians, pharmacists and specialists in SCD.…”

Section: Methodsmentioning

confidence: 99%

“…The complete description of study procedures is available in the publication of our study protocol [ 21 ]. Patient recruitment occurred where patients were treated, in RSCCA spread over metropolitan France and overseas departments, between September 2015 and December 2017.…”

Section: Methodsmentioning

confidence: 99%

Descriptive analysis of sickle cell patients living in France: The PHEDRE cross-sectional study

et al. 2021

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Background Sickle cell disease (SCD) induces chronic haemolytic anaemia and intermittent vaso-occlusion that results in tissue ischaemia causing acute, severe pain episodes that can lead to frequent hospitalizations. These consequences can have repercussions on family, social, school and/or professional life. Here, we present some of the results of the PHEDRE study (Pharmacodépendance Et DREpanocytose—drug dependence and sickle-cell disease), which is the largest study of patients with SCD in France. This paper intends to describe characteristics of the French SCD population. We also aimed to assess the impact of the disease on the lives of patients using objective and subjective variables. Methods The PHEDRE study was a national multicentric observational study. Adults, adolescents and children with a confirmed SCD diagnosis were included in the study by their referring doctor. Then, they were interviewed by phone about their socioeconomic status, about the impact of the disease on their lives and about their analgesic and psychoactive drug use. Results The study population consisted of 872 patients (28% were minors). Seventy-two percent of adults were active, and all minors were in school. Many patients presented criteria of severe SCD. Seventy-five percent were homozygous SS, 15% were double heterozygotes SC and 8% were heterozygotes Sβthal, 87% received specific treatment, 58% were hospitalized at least once for vaso-occlusive crisis in the past 12 months, and the number of analgesic drugs taken averaged 3.8. Seventy-five percent of patients reported academic or professional consequences related to their SCD, and 52% reported social consequences. Conclusions The impact of SCD on patients’ lives can be significant, nevertheless their social integration seems to be maintained. We highlighted respect of recommendations regarding analgesic treatments and only a few patients used tobacco, alcohol or cannabis. Trial registration Clinical Trials, NCT02580565; https://clinicaltrials.gov/ Registered 16 October 2015.

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“…The Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) is a valuable tool for managing pain 1 12. This gas inhalation is indicated for short-term procedural pain treatment in adults and children 13…”

Section: Introductionmentioning

confidence: 99%

“… 1 12 This gas inhalation is indicated for short-term procedural pain treatment in adults and children. 13 …”

Section: Introductionmentioning

confidence: 99%

Is the equimolar mixture of oxygen and nitrous oxide (EMONO) associated with audiovisuals effective in reducing pain and side effects during peripheral venous access placement in children? Protocol for a single-centre randomised controlled trial from Italy

Maiandi¹,

Ghizzardi²,

Edefonti

et al. 2023

BMJ Open

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IntroductionNurses frequently place a peripheral venous catheter during children’s hospitalisation. Many studies suggest treatment of venipuncture-related pain. The administration of an equimolar mixture of oxygen and nitrous oxide (EMONO) is employed for pain control; however, no studies have analysed the association between EMONO and audiovisuals.The purpose of the study is to evaluate the effect of EMONO administration when combined with audiovisuals (EMONO+Audiovisual) versus EMONO alone on perceived pain, side effects and level of cooperation during peripheral venous access placement in children aged 2–5 years.Methods and analysisThe first 120 eligible children admitted to the paediatric ward of the Lodi Hospital and presenting the indication for peripheral venous access will be enrolled. Sixty children will be randomly assigned to the experimental group (EMONO+Audiovisual) and 60 to the control group (EMONO alone).The Face, Legs, Activity, Cry, Consolability scale will be used to assess pain in the children aged 2-years old; pain in the children aged 3–5 years will be assessed using the Wong-Baker scale. The cooperation throughout the procedure will be measured using the Groningen Distress Rating Scale.Ethics and disseminationThe Milan Area 1 Ethics Committee approved the study protocol (Experiment Registry No. 2020/ST/295). The trial results will be presented at conferences and published in peer-reviewed journals.Trial registration numberNCT05435118.

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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

Cited by 5 publications

References 24 publications

Substance use disorder of equimolar oxygen-nitrous oxide mixture in French sickle-cell patients: results of the PHEDRE study

Substance use disorder of equimolar oxygen-nitrous oxide mixture in French sickle-cell patients: results of the PHEDRE study

Descriptive analysis of sickle cell patients living in France: The PHEDRE cross-sectional study

Is the equimolar mixture of oxygen and nitrous oxide (EMONO) associated with audiovisuals effective in reducing pain and side effects during peripheral venous access placement in children? Protocol for a single-centre randomised controlled trial from Italy

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