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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| post-cesarean patients | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trodon® Hemofarm | Drug | Consent was taken from each patient prior to the enrollment into the study during the first interview and 2 ml of blood was withdrawal for the CYP2D6 genotyping. After the cesarean section surgery, each patient received one dose of 100mg/2ml Trodon® Hemofarm for treating the postpartum pain and the patients were monitored for 24 hours. Follow-up was performed for each enrolled patient in which the VAS score, blood pressure, heart rate, oxygen saturation and any new effects after 1 hour, 6 hours of tramadol administration were recorded. In addition, after 24 hours evaluations for nocturnal pain, dietary state and bowel movement were performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale (10 cm) | Visual analog scale is used for measuring pain intensity on a scale of 0 to 10, in which a score on the line is marked by each patient ranging from "no pain" to "worst pain". The pain intensity increases as the score on the scale goes up. | after 1 hour and 6 hours of receiving single dose of tramadol |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure (mm of Hg) | Blood pressure was measured by automatic blood pressure monitor (mm of Hg) after 1 hour and 6 hours of IV tramadol administration to detect any change in the blood pressure of each patient. | after 1 hour and 6 hours of receiving single dose of tramadol |
| Heart rate (beats per minute) |
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Inclusion Criteria:
Exclusion Criteria:
female patients who were pregnant and indicated for elective cesarean section surgery for the delivery of singleton baby.
Pregnant patients who were indicated for elective cesarean section surgery at public hospital (Maternity Teaching hospital) located in Erbil city, Iraq were enrolled.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hawler Medical University/ College of Medicine | Erbil | 40/0112 | Iraq |
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2 ml of whole blood was collected in EDTA tube
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Pulse was recorded by pulse oximetry (beats per minute) after 1 hour and 6 hours of IV tramadol administration to detect any change in the heart rate of each patient. |
| after 1 hour and 6 hours of receiving single dose of tramadol |
| Oxygen saturation (SPO2%) | Oximetry was used (SPO2 %) for evaluating the oxygen saturation of each patient. | after 1 hour and 6 hours of receiving single dose of tramadol |
| Nocturnal pain | Evaluation of nocturnal pain was performed for each patient by a questionnaire after 24 hours to determine pain at night and whether it has impacted on the sleeping quality of the patient. | after 24 hours of receiving single dose of tramadol |
| Dietary state | Evaluation of dietary state was performed for each patient, in which the patient was asked after 24 hours to determine whether they have taken anything within the last 24 hours and if yes did they take liquid and/or solid food. | after 24 hours of receiving single dose of tramadol |
| Adverse effects | A questionnaire was presented to each patient for recording any newly appearing effects that are noticed by the patient after 1 hour and 6 hours of receiving single dose of tramadol drug intravenously. In addition, the patient was asked after 24 hours whether they had had bowel movement within the last 24 hours (whether the patient was constipated). | after 1 hour and 6 hours of receiving single dose of tramadol for recording any adverse effects, and after 24 hours of receiving single dose of tramadol for evaluation of the bowel movement (whether the patient was constipated). |