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

Epidermolysis Bullosa Clinical Trial

— ODEB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04853667
• Other study ID #: APHP210420
• Secondary ID: 2021-A00418-33
• Status: Completed
• Start date: April 29, 2021
• Est. completion date: May 20, 2021

Study information

• Verified date: May 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 20, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epidermolysis Bullosa

Intervention

Other:
• Interview
Semi-structured interview, lasting a maximum of one hour

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barriers to taking weak or strong opioid analgesics prescribed	Qualitative analysis of the semi-structured interview	Day 0
Secondary	Barriers to giving weak or strong opioid analgesics prescribed	Qualitative analysis of the semi-structured interview	Day 0