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Prospective Pharmacogenetic Cohort Study of CYP2D6 Metabolizer Phenotype, Analgesic Failure, and Adverse Effects in Postoperative Patients Receiving Tramadol by Elastomeric Infusion Pump

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This prospective pharmacogenetic cohort will enroll postoperative patients receiving a standardized tramadol-containing elastomeric analgesia pump. CYP2D6 genotype will be measured but will not determine treatment during the 72-hour study window. Participants with non-normal metabolizer phenotypes will be compared with normal metabolizers for analgesic treatment failure and adverse effects. Pain, rescue medication, pump discontinuation, sedation, respiratory status, nausea/vomiting, and other adverse events will be assessed at prespecified times.
Trial Details
NCT Number NCT07810816
Lead Sponsor Research Inc
Conditions
(from sponsor)		 Acute Postoperative Pain, Tramadol Adverse Effect, Pharmacogenetic Variation
Related terms Drug-Related Side Effects and Adverse Reactions, Postoperative Pain
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov