Pruritus Caused by DrugPhase 1NCT06297499
Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section
A Phase 1 study testing Ondansetron 8mg in people with Pruritus Caused by Drug, run by Wayne State University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pruritus Caused by Drug
- What is being tested?
- Ondansetron 8mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2024to 1 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status 1-3
- Adult parturient (18 -50 years of age) scheduled to undergo elective cesarean delivery under spinal anesthesia
- Patients must be willing and cognitively able to give written informed study consent
Who cannot join
- Patients with an ASA physiological assessment greater than grade 3
- Allergies to local anesthetics, opioids, or ondansetron
- Coagulopathies precluding provision of spinal anesthesia
- Pre-eclampsia with severe features
- Eclampsia
- Pre-intrathecal pruritus
Show all 24Show fewer
- Psychiatric or language deficiencies affecting assessment of pain
- Insufficient understanding of the pain scoring system
- Patients who receive any other regional anesthesia techniques
- Patients on higher than a 100mg of daily morphine equivalent
- Cardiac issues that would preclude spinal anesthesia (Congestive heart failure, Mitral or Aortic valve pathology.
- Confounding neural issues that would preclude spinal anesthesia.
- Coadministration of drugs that would potentially interact with ondansetron. Including Apomorphine, Phenytoin, Carbamazepine, Rifampicin, Tramadol and Chemotherapy drugs.
- Coadministration of drugs that would potentially prolong QTc interval. Including Antiarrhythmic, Antidepressants, Antipsychotics, and the following list of medications.
- Levofloxacin, Ciprofloxacin, Gatifloxacin, Moxifloxacin, Clarithromycin, Erythromycin, Ketoconazole, Itraconazole, Cisapride, Sumatriptan, Zolmitriptan, Arsenic, Dolasetron, Methadone
- Coadministration of drugs that would potentially lead to the development of serotonin syndrome. Including the following:
- 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
- Patients having the following
- Patients known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any components of the formulation
- Concomitant use of apomorphine
- History of QTc interval prolongation (QTc >440) and Torsade de Pointes
- Serotonin syndrome
- Phenylketonuric patients
- Concurrent use of selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Detroit Medical Center- Hutzel Women's Hospital
Detroit, Michigan, 48201
George M McKelvey, PhD, 3135986036, gmckelve@dmc.org
Justin Hruska, MD, 402-432-0985, justinhruska1@gmail.com
About this study
Official title: Timing of Ondansetron Use for Maximum Efficacy in Preventing Pruritus in Patients Undergoing Cesarean Section Under Spinal Anesthesia with Preservative Free Morphine.
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.
Read the 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.
- Conditions
- Pruritus Caused by Drug
- Being tested
- Ondansetron 8mg
- Keywords
- Cesarean Section, Intrathecal Morphine, Ondansetron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 8mgDrug
Also called Placebo- 4ml of 0.9% IV saline
administration of an IV solution of 8mg ondansetron (4ml)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1. Pre-Intrathecal | Experimental | Patients will receive an IV solution of 8mg ondansetron (4ml) within 30 minutes of the standard-of-care anesthetic treatment (intrathecal morphine administration) followed by a placebo treatment of an IV solution of 4ml 0.9% saline administered at the time of umbilical cord clamping. Receives: Drug: Ondansetron 8mg |
| Treatment Group 2 Cord clamping | Active comparator | Patients will receive a placebo treatment of an IV solution of 4ml 0.9% saline administered within 30 minutes of the standard-of-care anesthetic treatment (intrathecal morphine administration) followed by an IV solution of 8mg ondansetron (4ml) administered at the time of umbilical cord clamping. Receives: Drug: Ondansetron 8mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pruritus parameters in Post anesthesia Care Unit (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
Measured: Assessment during 1st post-operative hour in PACU
Pruritus severity in Post anesthesia Care Unit (PACU)
Severity of Pruritus- Likert scale choices from (Not present, Mild, Moderate, Severe, Unbearable) severity
Measured: Assessment during 1st post-operative hour in PACU
Pruritus parameters PACU
Patient Assessment (patient questionnaire): Pruritus occurrence (Yes or no) and anatomical location of pruritus location
Measured: Assessment during 24 hours post-operative period
Pruritus severity PACU
Patient Assessment (patient questionnaire): Pruritus Severity: Likert scale: choice of (Not present, Mild, Moderate, Severe, Unbearable)
Measured: Assessment during 24 hours post-operative period
Rescue Pruritus Treatment medication
Patient Assessment questionnaire: If rescue Pruritus treatment was required (YES/NO) and if so specific medication type and dose amount of medication
Measured: Measured in the 24 hour period from initial study treatment (30 minute period before intrathecal morphine administration.
Nausea PACU
Patient Assessment questionnaire: Severity of Nausea- Likert scale: choice of (Not present, Mild, Moderate, Severe, Unbearable)
Measured: Assessment every 15 minutes for 1 hour
Nausea Post PACU
Patient Assessment questionnaire: Severity of Nausea- Likert scale: choice of (Not present, Mild, Moderate, Severe, Unbearable)
Measured: our period after patients left PACU from initial study treatment (30 minute period before intrathecal morphine administration.
Secondary outcomes (1)
Post-operative Pain
Patient assessment questionnaire: Visual analog pain scale (VAS) measuring scores from 0 (no pain)-10 (worst pain) at rest
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start22 Aug 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pruritus Caused by DrugStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blinded trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Hruska, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297499
- Sponsor's protocol ID
- IRB-22-07-4803
- Status last verified
- Mar 2025
- First submitted
- 13 Feb 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Ondansetron Use for Maximum Efficacy in Preventing Pruritus in Patients Undergoing Cesarean Section Under Spinal Anesthesia with Preservative Free Morphine.
- ClinicalTrials.gov ID
- NCT06297499
- Acronym / sponsor ID
- IRB-22-07-4803
- Conditions
- Pruritus Caused by Drug
- Keywords
- Cesarean Section, Intrathecal Morphine, Ondansetron
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blinded trial
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1. Pre-Intrathecal | Experimental | Drug: Ondansetron 8mgPatients will receive an IV solution of 8mg ondansetron (4ml) within 30 minutes of the standard-of-care anesthetic treatment (intrathecal morphine administration) followed by a placebo treatment of an IV solution of 4ml 0.9% saline administered at the time of umbilical cord clamping. |
| Treatment Group 2 Cord clamping | Active comparator | Drug: Ondansetron 8mgPatients will receive a placebo treatment of an IV solution of 4ml 0.9% saline administered within 30 minutes of the standard-of-care anesthetic treatment (intrathecal morphine administration) followed by an IV solution of 8mg ondansetron (4ml) administered at the time of umbilical cord clamping. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status 1-3
- Adult parturient (18 -50 years of age) scheduled to undergo elective cesarean delivery under spinal anesthesia
- Patients must be willing and cognitively able to give written informed study consent
Key exclusion criteria (24 listed)
- Patients with an ASA physiological assessment greater than grade 3
- Allergies to local anesthetics, opioids, or ondansetron
- Coagulopathies precluding provision of spinal anesthesia
- Pre-eclampsia with severe features
- Eclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ondansetron 8mgAlso: Placebo- 4ml of 0.9% IV salineadministration of an IV solution of 8mg ondansetron (4ml) | Drug | Treatment Group 1. Pre-Intrathecal, Treatment Group 2 Cord clamping |
Primary outcome
Pruritus parameters in Post anesthesia Care Unit (PACU)
Time frame: 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
Pruritus severity in Post anesthesia Care Unit (PACU)
Time frame: Assessment during 1st post-operative hour in PACU
Severity of Pruritus- Likert scale choices from (Not present, Mild, Moderate, Severe, Unbearable) severity
Pruritus parameters PACU
Time frame: Assessment during 24 hours post-operative period
Patient Assessment (patient questionnaire): Pruritus occurrence (Yes or no) and anatomical location of pruritus location
Pruritus severity PACU
Time frame: Assessment during 24 hours post-operative period
Patient Assessment (patient questionnaire): Pruritus Severity: Likert scale: choice of (Not present, Mild, Moderate, Severe, Unbearable)
Rescue Pruritus Treatment medication
Time frame: 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
Nausea PACU
Time frame: Assessment every 15 minutes for 1 hour
Patient Assessment questionnaire: Severity of Nausea- Likert scale: choice of (Not present, Mild, Moderate, Severe, Unbearable)
Nausea Post PACU
Time frame: 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)
1 secondary outcome
Post-operative Pain
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ondansetron 8mg in people with Pruritus Caused by Drug, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin Hruska, MD (402-432-0985, justinhruska1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pruritus parameters in Post anesthesia Care Unit (PACU) (time frame: Assessment during 1st post-operative hour in PACU). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.