Assessment of Opioid Analgesia in Sickle Cell

• Status: Withdrawn
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To develop and validate a non-invasive, in vivo, phenotyping method for CYP2D6 using the non-injurious neuroselective electrical stimulation technique: pain perception threshold/pain tolerance threshold (PPT/PTT) in children and adolescents with sickle cell disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's National Research Institute; Children's Research Institute
• Treatments: Analgesics, Opioid; Codeine; Dextromethorphan; Morphine

Criteria

Inclusion Criteria:

• The subject is 7 to 18 years of age

• The subject is of African American descent

• The subject has sickle cell disease (HbSS)

• The subject has a history of vaso-occlusive crisis occurring within the 6 months prior to enrollment requiring opioid analgesia use

• The subject is willing to remain at the research site for the duration of each study session.

• The subject's parent / legal guardian has provided written informed consent to study participation

• The subject has provided written assent to study participation

Exclusion Criteria:

• The subject is a pregnant or lactation female (if post-menarchal, a negative pregnancy test must be confirmed on the day that any drug is administered (i.e., morphine, dextromethorphan or codeine)

• The subject has a history of smoking

• The subject has a history of alcohol use within the last 24 hours prior to testing session(s)

• The subject has a medical history of neuropathic pain, gastrointestinal, hepatic or renal disease

• The subject has a history of medication use including herbal therapies that are known to inhibit or induce CYP2D6 or morphine

• The subject has known or suspected hypersensitivities / allergies to codeine, morphine or dextromethorphan

• The subject is in active, vaso-occlusive crisis