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

NCT04853667 | Completed

• 2 other identifiers: APHP2104202021-A00418-33
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epidermolysis Bullosa

Keywords

Hereditary epidermolysis bullosa (HEB); Pain control; Analgesic treatments

Outcome Measures

Primary Outcomes (1)

• Barriers to taking weak or strong opioid analgesics prescribed

  Qualitative analysis of the semi-structured interview

  Day 0

Secondary Outcomes (1)

• Barriers to giving weak or strong opioid analgesics prescribed

  Day 0

Study Arms (2)

Patients with hereditary epidermolysis bullosa

Minor patients with hereditary epidermolysis bullosa

Other: Interview

Parents

Parents of patients with hereditary epidermolysis bullosa

Other: Interview

Interventions

Interview OTHER

Semi-structured interview, lasting a maximum of one hour

Parents; Patients with hereditary epidermolysis bullosa

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Epidermolysis Bullosa; Agnosia

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sarah Chaumon

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Céline Greco, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: April 29, 2021
• Primary Completion: May 20, 2021
• Study Completion: May 20, 2021
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)