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

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

Sponsors

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Source Assistance Publique - Hôpitaux de Paris
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.

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.

Overall Status Not yet recruiting
Start Date 2021-04-01
Completion Date 2021-08-01
Primary Completion Date 2021-08-01
Study Type Observational
Primary Outcome
Measure Time Frame
Barriers to taking weak or strong opioid analgesics prescribed Day 0
Secondary Outcome
Measure Time Frame
Barriers to giving weak or strong opioid analgesics prescribed Day 0
Enrollment 10
Condition
Intervention

Intervention Type: Other

Intervention Name: Interview

Description: Semi-structured interview, lasting a maximum of one hour

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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

Gender:

All

Minimum Age:

6 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Sarah Chaumon

Phone: 1 44 49 56 77

Phone Ext.: +33

Email: [email protected]

Location
Facility: Contact: Hôpital Necker-Enfants Malades Sarah Chaumon 1 44 49 56 77 +33 [email protected]
Location Countries

France

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Patients with hereditary epidermolysis bullosa

Description: Minor patients with hereditary epidermolysis bullosa

Label: Parents

Description: Parents of patients with hereditary epidermolysis bullosa

Acronym ODEB
Patient Data No
Study Design Info

Observational Model: Family-Based

Time Perspective: Prospective

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