Status:

COMPLETED

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

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Collaborating Sponsors:

URC-CIC Paris Descartes Necker Cochin

Conditions:

Epidermolysis Bullosa

Eligibility:

All Genders

6+ years

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...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 29 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 20 2021

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT04853667

Start Date

April 29 2021

End Date

May 20 2021

Last Update

September 15 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Hôpital Necker-Enfants Malades

Paris, France, 75015