Improve Adherence to Weak or Strong Opioid Analgesics at the Time of Care in Children With Hereditary Epidermolysis Bullosa (ODEB)

Hereditary epidermolysis bullosa (HEB) are rare genodermatoses, clinically characterized by epithelial and subepithelial fragility leading to the formation of blisters and spontaneous erosions on skin at the slightest contact, with possible mucosal damage.

The care of these patients consists of therapeutic baths leading to renew bandages that sometimes covering the entire integument. These are difficult, delicate and painful moments that patients experience daily at home.

For an unexplained reason for 70 to 80% of them, the weak or strong opioid analgesics, deemed necessary and prescribed for good pain control, are not taken on a regular basis as a premedication for baths and dressing changes.

The aim of the study is to understand the child's brakes on taking weak or strong opioid analgesics at the time of care and the parents' difficulties in giving these treatments by means of individual interviews.

Study Overview

• Status: Completed
• Conditions: Epidermolysis Bullosa
• Intervention / Treatment: Other: Interview

Detailed Description

Hereditary epidermolysis bullosa (HEB) are rare genodermatoses, clinically characterized by epithelial and subepithelial fragility leading to the formation of blisters and spontaneous erosions on skin at the slightest contact, with possible mucosal damage.

The Pain Medicine and Palliative Medicine Functional Unit (UFMDP) of Necker Hospital is involved on a daily basis in supporting the complex and multidisciplinary management of patients with the most serious forms of hereditary epidermolysis bullosa and their family.

The care of these patients consists of therapeutic baths leading to renew bandages that sometimes covering the entire integument. These are difficult, delicate and painful moments that patients experience daily at home.

The medical and paramedical professionals, from the UFMDP and from the reference center for Genetic Diseases with Cutaneous Expression (MAGEC) (Dermatology Department) of the Necker Hospital, surrounding these children, note that for an unexplained reason for 70 to 80% of them, the weak or strong opioid analgesics, deemed necessary and prescribed for good pain control, are not taken on a regular basis as a premedication for baths and dressing changes.

Care is painful, increasing the vicious circle of anxiety, conflict with caregivers, family and ultimately pain.

The aim of the study is to understand the child's brakes on taking weak or strong opioid analgesics at the time of care and the parents' difficulties in giving these treatments by means of individual interviews.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hôpital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents with hereditary epidermolysis bullosa, follow-ups at the reference center for genetic diseases with cutaneous expression (MAGEC), dermatology department of Necker hospital and their parents.

Description

Inclusion Criteria:

• Francophone children and adolescents with hereditary epidermolysis bullosa and of an age to express themselves verbally
• French-speaking holders of parental authority
• Regular follow-ups at the reference center for genetic diseases with cutaneous expression (MAGEC), dermatology department of Necker hospital
• Pain at the time of treatment, the evaluation of which is greater than 4/10 (visual analogue scale VAS) without taking weak or strong opioid analgesics, yet prescribed as premedication
• Holders of parental authority and patients informed and not opposing their participation in the study

Exclusion Criteria:

• Children and adolescents without pain at the time of treatment or for whom paracetamol is sufficient to obtain good pain control
• Children and adolescents already taking analgesic treatments even if their pain is not well balanced at the time of care

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with hereditary epidermolysis bullosa; Minor patients with hereditary epidermolysis bullosa	Other: Interview; Semi-structured interview, lasting a maximum of one hour
Parents; Parents of patients with hereditary epidermolysis bullosa	Other: Interview; Semi-structured interview, lasting a maximum of one hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers to taking weak or strong opioid analgesics prescribed	Qualitative analysis of the semi-structured interview	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers to giving weak or strong opioid analgesics prescribed	Qualitative analysis of the semi-structured interview	Day 0

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Study Director: Céline Greco, MD, Assistance Publique - Hôpitaux de Paris; Principal Investigator: Sarah Chaumon, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Understanding noncompliance with opioid-based analgesic premedications in the care of children with hereditary epidermolysis bullosa Authors : Sarah Chaumon, Christine Bodemer, Céline Greco Douleurs : Évaluation - Diagnostic - Traitement Volume 23, Issue 1, February 2022, Pages 14-24

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Actual): May 20, 2021
• Study Completion (Actual): May 20, 2021

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pain control; Hereditary epidermolysis bullosa (HEB); Analgesic treatments
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Genetic Diseases, Inborn; Neurobehavioral Manifestations; Skin Diseases; Congenital Abnormalities; Skin Diseases, Genetic; Skin Abnormalities; Skin Diseases, Vesiculobullous; Perceptual Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Epidermolysis Bullosa; Agnosia; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic
• Other Study ID Numbers: APHP210420; 2021-A00418-33 (Other Identifier: ID RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No