Pruritus Caused by Drug
Conditions
Keywords
Cesarean Section, Intrathecal Morphine, Ondansetron
Brief summary
Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N/V in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration.
Detailed description
Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N/V in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration. The primary aim of this study is to observe in a randomized double-blinded trial if the timing of prophylactic administration of intravenous ondansetron can reduce the incidence and severity of intrathecal morphine-induced pruritus in patients undergoing Cesarean section (CS). The secondary aim is to establish the effect of intravenous ondansetron given at different time intervals following CS for postoperative nausea and vomiting (PONV). The primary study hypothesis is that patients receiving prophylactic intravenous ondansetron (15-30 minutes prior to intrathecal morphine) will experience a lower incidence and severity of intrathecal morphine-induced pruritus than patients receiving ondansetron administered at the time of umbilical cord clamping. The secondary study hypothesis is that CS patients receiving intravenous ondansetron 15-30 minutes prior to intrathecal morphine will have less nausea and vomiting than patients receiving ondansetron administered at the time of umbilical cord clamping. As the effect of prophylactic administration of ondansetron in reducing pruritus or Nausea/Vomiting in cesarean section (CS) cases has not been studied and thus, this prospective study may help guide future clinical management of side effects caused by intrathecal morphine administration.
Interventions
DRUGOndansetron 8mg
administration of an IV solution of 8mg ondansetron (4ml)
Sponsors
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The patient will be unaware of their grouping allotment. The outcomes assessor will be unaware of the patient grouping allotment.
Intervention model description
Randomized double-blinded trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. American Society of Anesthesiologists (ASA) physical status 1-3 2. Adult parturient (18 -50 years of age) scheduled to undergo elective cesarean delivery under spinal anesthesia 3. Patients must be willing and cognitively able to give written informed study consent
Exclusion criteria
1. Patients with an ASA physiological assessment greater than grade 3 2. Allergies to local anesthetics, opioids, or ondansetron 3. Coagulopathies precluding provision of spinal anesthesia 4. Pre-eclampsia with severe features 5. Eclampsia 6. Pre-intrathecal pruritus 7. Psychiatric or language deficiencies affecting assessment of pain 8. Insufficient understanding of the pain scoring system 9. Patients who receive any other regional anesthesia techniques 10. Patients on higher than a 100mg of daily morphine equivalent 11. Cardiac issues that would preclude spinal anesthesia (Congestive heart failure, Mitral or Aortic valve pathology. 12. Confounding neural issues that would preclude spinal anesthesia. 13. Coadministration of drugs that would potentially interact with ondansetron. Including Apomorphine, Phenytoin, Carbamazepine, Rifampicin, Tramadol and Chemotherapy drugs. 14. Coadministration of drugs that would potentially prolong QTc interval. Including Antiarrhythmic, Antidepressants, Antipsychotics, and the following list of medications. a. Levofloxacin, Ciprofloxacin, Gatifloxacin, Moxifloxacin, Clarithromycin, Erythromycin, Ketoconazole, Itraconazole, Cisapride, Sumatriptan, Zolmitriptan, Arsenic, Dolasetron, Methadone 15. Coadministration of drugs that would potentially lead to the development of serotonin syndrome. Including the following: a. Selective serotonin reuptake inhibitors, Serotonin and norepinephrine reuptake inhibitors, antidepressants, carbamazepine , valproic acid, triptans, Chronic pain medications prior to procedure (Fentanyl, Hydrocodone, Meperidine, Oxycodone, tramadol),Lithium, dextromethorphan, Linezolid and Ritonavir 16. Patients having the following 1. Patients known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any components of the formulation 2. Concomitant use of apomorphine 3. History of QTc interval prolongation (QTc \>440) and Torsade de Pointes 4. Serotonin syndrome 5. Phenylketonuric patients 6. Concurrent use of selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pruritus parameters in Post anesthesia Care Unit (PACU) | Assessment during 1st post-operative hour in PACU | Patient Assessment (patient questionnaire): Pruritus occurrence (Yes or no) and anatomical location of Pruritus of occurrence, Severity of Pruritus- Likert scale choices from (Not present, Mild, Moderate, Severe, Unbearable) severity |
| Nausea Post PACU | our period after patients left PACU from initial study treatment (30 minute period before intrathecal morphine administration. | Patient Assessment questionnaire: Severity of Nausea- Likert scale: choice of (Not present, Mild, Moderate, Severe, Unbearable) |
| Nausea PACU | Assessment every 15 minutes for 1 hour | Patient Assessment questionnaire: Severity of Nausea- Likert scale: choice of (Not present, Mild, Moderate, Severe, Unbearable) |
| Rescue Pruritus Treatment medication | Measured in the 24 hour period from initial study treatment (30 minute period before intrathecal morphine administration. | Patient Assessment questionnaire: If rescue Pruritus treatment was required (YES/NO) and if so specific medication type and dose amount of medication |
| Pruritus severity PACU | Assessment during 24 hours post-operative period | Patient Assessment (patient questionnaire): Pruritus Severity: Likert scale: choice of (Not present, Mild, Moderate, Severe, Unbearable) |
| Pruritus parameters PACU | Assessment during 24 hours post-operative period | Patient Assessment (patient questionnaire): Pruritus occurrence (Yes or no) and anatomical location of pruritus location |
| Pruritus severity in Post anesthesia Care Unit (PACU) | Assessment during 1st post-operative hour in PACU | Severity of Pruritus- Likert scale choices from (Not present, Mild, Moderate, Severe, Unbearable) severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain | Taken while patient in PACU at 0 minutes, 15 minutes, 30 minutes, 45 minutes and 60 min. Post PACU patient assessment at at 8 hours, 16 hours, 24 hours post-operative period | Patient assessment questionnaire: Visual analog pain scale (VAS) measuring scores from 0 (no pain)-10 (worst pain) at rest |
Other
| Measure | Time frame | Description |
|---|---|---|
| Peripheral oxygen saturation- Mother | At Delivery, then at 30 minutes, 60 minutes, 90 minutes, 2 hours, 8 hours,16 hours, 24 hours post-delivery | Clinical Measurement of patient Peripheral blood oxygen saturation (percentage %) via a pulse oximeter |
| ECG Infant | Within 2 hours of birth. | ECG parameters (ECG QT intervals) interpreted by a by a trained Cardiologist |
| Electrocardiogram (ECG ) Mother | Within 2 hours of birth. | ECG parameters (ECG QT intervals) interpreted by a by a trained Cardiologist |
| Blood pressure- Infant | At Delivery, then at 30 minutes, 60 minutes, 90 minutes, 2 hours, 8 hours,16 hours, 24 hours post-delivery | Clinical Measurement of patient blood pressure (Diastolic/Systolic pressure mm/Hg) 0 |
| Blood pressure Mother | At Delivery, then at 30 minutes, 60 minutes, 90 minutes, 2 hours, 8 hours,16 hours, 24 hours post-delivery | Clinical Measurement of patient blood pressure (Diastolic/Systolic pressure mm/Hg) 0 |
| Heart rate- Infant | At Delivery, then at 30 minutes, 60 minutes, 90 minutes, 2 hours, 8 hours,16 hours, 24 hours post-delivery | Clinical Measurement of patient heart rate (beats per minute) via a pulse oximeter |
| Heart rate- Mother | At Delivery, then at 30 minutes, 60 minutes, 90 minutes, 2 hours, 8 hours,16 hours, 24 hours post-delivery | Clinical Measurement of patient heart rate (beats per minute) via a pulse oximeter |
| Peripheral oxygen saturation- Infant | At Delivery, then at 30 minutes, 60 minutes, 90 minutes, 2 hours, 8 hours,16 hours, 24 hours post-delivery | Clinical Measurement of patient Peripheral blood oxygen saturation (percentage %) via a pulse oximeter |
Countries
United States
Contacts
Primary ContactJustin Hruska, MD
Backup ContactGeorge M McKelvey, PhD
Outcome results
None listed