Ondansetron for Drug-Induced Itching

Overseen By George M McKelvey, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Wayne State University

Must not be taking: Antidepressants, Antipsychotics, Chemotherapy, others

Disqualifiers: Pre-eclampsia, Eclampsia, Cardiac issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate perioperative period

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how ondansetron, a common anti-nausea medication, can reduce itching and nausea caused by opioids used in spinal anesthesia during C-sections. Participants will receive ondansetron either before or after delivery to determine which timing more effectively manages these side effects. The trial seeks pregnant individuals scheduled for a C-section who have no allergies to the medications involved and can safely receive spinal anesthesia. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to early-stage medical research.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial, especially if they interact with ondansetron or affect heart rhythm. These include some antidepressants, pain medications, and antibiotics. It's best to discuss your current medications with the trial team to see if any changes are needed.

Is there any evidence suggesting that ondansetron is likely to be safe for humans?

Research has shown that ondansetron is generally safe for people. It is often administered to prevent nausea and vomiting in various medical situations. Ondansetron is particularly common during pregnancy to manage anesthesia side effects, such as itching, during procedures like cesarean deliveries.

Most people tolerate ondansetron well, but some may experience side effects. Common side effects include headaches and constipation. Serious side effects are rare but can occur, such as breathing problems and heart issues.

Overall, ondansetron is considered safe, especially for preventing nausea. Monitoring for any unusual reactions when taking it is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for drug-induced itching focus on symptomatic relief using antihistamines or corticosteroids. However, ondansetron is unique because it targets the serotonin receptors, which are believed to play a role in itching caused by certain drugs like opioids. Researchers are excited about ondansetron because it offers a novel mechanism of action by blocking serotonin 5-HT3 receptors, which could potentially provide more effective relief from itching with fewer side effects. Additionally, the trial explores different timings of administration—either before the standard anesthetic treatment or at the time of umbilical cord clamping—further highlighting its potential to enhance current treatment protocols.

What evidence suggests that ondansetron might be an effective treatment for drug-induced itching?

Research has shown that ondansetron can help reduce itching caused by certain medications. One study found that patients who took ondansetron experienced less itching than those who did not. Another study showed that ondansetron reduced itching from spinal anesthesia during cesarean deliveries from 36% to 14%. Ondansetron works by blocking serotonin, a chemical in the body that can cause itching. In this trial, participants will be divided into two groups: one group will receive ondansetron before the standard-of-care anesthetic treatment, and the other group will receive it at the time of umbilical cord clamping. Overall, these findings suggest that ondansetron could be a promising option to manage itching for patients receiving opioids during surgery. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for pregnant women undergoing cesarean section who experience itching due to spinal opioids used in anesthesia. Participants should not have any conditions that would make using Ondansetron unsafe.

Inclusion Criteria

My health is good to moderately impaired.

I am willing and able to consent to participate in the study.

I am between 18 and 50 years old and scheduled for a C-section with spinal anesthesia.

Exclusion Criteria

I have been diagnosed with serotonin syndrome.

I am not taking medications that increase serotonin levels.

Insufficient understanding of the pain scoring system

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intravenous ondansetron at different time intervals to assess its efficacy in reducing pruritus and nausea during cesarean section

Immediate perioperative period

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for pruritus, nausea, and other vital signs during the post-operative period

24 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Ondansetron

Trial Overview The study tests if giving Ondansetron (8mg) at different times can reduce itching or nausea and vomiting caused by opioids added to local anesthetics during cesarean sections. It's a prospective study, meaning it observes outcomes over time.

How Is the Trial Designed?

Group I: Treatment Group 1. Pre-Intrathecal Experimental Treatment 1 Intervention

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.

Group II: Treatment Group 2 Cord clamping Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

Published Research Related to This Trial

Ondansetron effectively controlled acute emesis in 53% of patients on a specific dosing schedule after non-cisplatin-based chemotherapy, demonstrating its potential as a treatment for those previously resistant to standard antiemetics.

The drug maintained its antiemetic efficacy across multiple treatment cycles, with no major toxicity reported, making it a safe option for patients experiencing chemotherapy-induced nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 5-HT3 receptor antagonist ondansetron re-establishes control in refractory emesis induced by non-cisplatin chemotherapy. Seynaeve, C., de Mulder, PH., Lane-Allman, E., et al.[2019]

Ondansetron, administered intravenously at 4 mg once daily for 3-5 days, effectively controlled nausea in 59% and emesis in 68% of patients receiving non-platinum anticancer drugs, demonstrating its efficacy as an anti-emetic.

The safety profile of Ondansetron was strong, with 98% of cases showing no safety issues, and only minor side effects like headache and constipation reported in a few instances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Examination of anti-emetic effect and safety of multiple intravenous doses of ondansetron in patients receiving nonplatinum anti-cancer drugs]. Nukariya, N., Niitani, H., Taguchi, T., et al.[2013]

Intranasal zolmitriptan provides rapid relief for migraine sufferers, with plasma drug levels detectable within 2 minutes and central nervous system effects occurring just 3 minutes later, showing significant efficacy compared to placebo within 10 to 15 minutes after administration.

This formulation is particularly beneficial for patients who prefer not to self-inject or who experience gastrointestinal issues, highlighting its potential as a preferred option for acute migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zolmitriptan intranasal: a review of the pharmacokinetics and clinical efficacy. Goadsby, PJ., Yates, R.[2014]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37167702/

Ondansetron for the Prevention of Pruritus in Women ... Patients who received ondansetron showed a significant reduction in the incidence of pruritus compared to the control group (RR, 0.81; 95% ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405857220300152

Effectiveness of prophylactic intravenous ondasetron to ... In our study IV ondansetron significantly reduced the incidence of intrathecal fentanyl induced pruritus from 36% to 14% in patients undergoing cesarean ...

3. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/189209

Successful Treatment of Intractable Palmoplantar Pruritus ... This trial showed at least a 50% reduction of itching in all 10 patients. Itching can only be assessed subjectively.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9540995/

Intravenous ondansetron reduced nausea but not pruritus ... This study found no evidence for intravenous ondansetron as an effective preventative for pruritus following intrathecal morphine in children.

5. journals.lww.com journals.lww.com/ejanaesthesiology/fulltext/2000/00002/ondanseron_prevent_itching_observed_after_opioids.358.aspx

Ondanseron prevent itching observed after opioids used... Conclusions: Ondansetron is highly effective medication in preventing skin pruritus after intrathecal administration of opioids. There are no differences in ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2016/020103s035_020605s019_020781s019lbl.pdf

ZOFRAN (ondansetron hydrochloride) Label The safety and effectiveness of orally administered ZOFRAN have been established in pediatric patients 4 years and older for the prevention of nausea and ...

7. webmd.com webmd.com/drugs/2/drug-30/zofran-oral/details

Ondansetron (Zofran, Zofran ODT, Zuplenz) - Uses, Side ... What are the serious side effects of ondansetron? · Breathing problems or wheezing · Racing heart · Fever or general ill feeling · Swollen lymph ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK499839/

Ondansetron - StatPearls - NCBI Bookshelf - NIH Ondansetron is a widely prescribed medication for nausea and vomiting from various causes. The drug is relatively safe, but prescribers, including nurse ...

9. rxlist.com rxlist.com/ondansetron/generic-drug.htm

Ondansetron: Side Effects, Uses, Dosage, Interactions, ... Ondansetron is used alone or with other medications to prevent nausea and vomiting. Learn about side effects, drug interactions, dosages, warnings, ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8122120/

Fatal anaphylaxis to intravenous ondansetron: A case report The safety and efficacy of ondansetron has led to its wider clinical use and this could increase unusual serious adverse events.