The Impact of CYP2D6 Polymorphism on Tramadol Pharmacodynamics

Elweyia Maternity Teaching Hospital

Status: Active, not recruiting

Conditions: Tramadol Resistance; CYP2D6 Polymorphism; Post-cesarean Pain

Treatments: Drug: Trodon® Hemofarm

Study type: Observational

Funder types: Other

Identifiers

NCT06814652

ElweyiaMTH

Details and patient eligibility

About

CYP2D6 is an enzyme involved in the hepatic metabolism of many clinically important drugs: antiarrhythmics, antidepressants, antipsychotics, β-blockers, and analgesics such as tramadol and codeine. CYP2D6 is highly polymorphic and significant interindividual variability has been observed worldwide. This study aims to investigate the distribution of CYP2D6 polymorphisms among post-cesarean female patients in Erbil city, Iraq. The findings of this study may indicate the presence of CYP2D6 gene variants among the Kurdish female population in Erbil, which could contribute to tramadol analgesic failure or exaggerated adverse effects. This study could also serve as a foundation for further pharmacogenetic research, individualizing treatments and targeting a larger sample size in the future.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients aged between 18-56 years old
• Patients who undergo cesarean section surgery
• Patients receive tramadol drug for postpartum pain management

Exclusion criteria

• Patients with any history of severe renal, liver, respiratory diseases and/or seizures
• Patients with history of psychiatric disorders or unable to provide consent
• Patients with complicated surgeries or neonatal distress or unable to perform the clinical assessment of pain
• Patients with history of consumption of chronic alcohol or opioid or drug abuse
• Patients with history of known allergy to tramadol

Trial design

40 participants in 1 patient group

post-cesarean patients

Description:

All of these patients were planned to undergo elective cesarean surgery and receive postpartum management for twenty-four hours at the Erbil Maternity and Childbirth Hospital. Consent was taken from each patient prior to the enrollment into the study. Their age ranged between 21-42 years. Patients received one dose of tramadol drug (100mg/2ml of Trodon® Hemofarm) intravenously for management of postpartum pain after gaining back their pain sensation.

Treatment:

Drug: Trodon® Hemofarm