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

Brief Title

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

Official Title

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

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.
    

Study Type

Observational

Primary Outcome

Barriers to taking weak or strong opioid analgesics prescribed

Secondary Outcome

 Barriers to giving weak or strong opioid analgesics prescribed

Condition

Epidermolysis Bullosa

Intervention

Interview

Study Arms / Comparison Groups

 Patients with hereditary epidermolysis bullosa

Description:  Minor patients with hereditary epidermolysis bullosa

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

10

Start Date

April 29, 2021

Completion Date

May 20, 2021

Primary Completion Date

May 20, 2021

Eligibility 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

Ages

6 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sarah Chaumon, , 

Location Countries

France

Location Countries

France

NCT ID

NCT04853667

Organization ID

APHP210420

Secondary IDs

2021-A00418-33

Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris

Study Sponsor

Sarah Chaumon, Principal Investigator, Assistance Publique - Hôpitaux de Paris

Verification Date

May 2021