Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy

Study Overview
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Brief Summary
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Between fifty and eighty percent of pregnant women experience nausea and vomiting in pregnancy making it one of the most common medical complications of pregnancy. Hyperemesis gravidarum is an extreme form of nausea and vomiting of pregnancy and results in evidence of acute starvation (i.e. large ketonuria), and weight loss (>5% of a woman's pre-pregnancy weight). Hyperemesis gravidarum is also surprisingly common. In fact, it is the second leading cause of preterm hospitalization during pregnancy, second only preterm labor. Hospitalization is often required because hyperemesis is frequently refractory to common anti-nausea medications. However, capsaicin cream, a potent TRPV1 agonist, commonly used to relieve muscular and neuropathic pain, may be able to reduce the symptoms of nausea and emesis in patients with nausea and vomiting of pregnancy. Smaller studies have demonstrated capsaicin to be both safe and effective when used to treat intraoperative nausea during cesarean delivery. To begin to address whether capsaicin cream could be used to reduce preterm admissions and shorten emergency room visits for hyperemesis, this study will randomize women presenting to the emergency room for nausea and vomiting to treatment with capsaicin cream as an adjunctive medication or routine care. The project will investigate the impact of capsaicin cream on hospital length of stay as well as representation for additional treatment. If effective, capsaicin cream has the potential not only to reduce emergency room visits, hospital admissions and overall health care costs, but also to drastically improve patient quality of life.

Official Title
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Trial of Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy: A Pilot Investigation

Conditions
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Hyperemesis Gravidarum, Nausea Gravidarum, Vomiting of Pregnancy

Intervention / Treatment
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* Drug: Capsaicin Topical Cream
* Drug: Metoclopramide
* Drug: Ondansetron
* Drug: Lactated Ringers, Intravenous


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women in the first trimester (0-14 weeks gestation) Presenting to the emergency room at Women & Infants Hospital in Rhode Island with a chief complaint of nausea and vomiting English or Spanish speaking Have not taken an anti-emetic such as Reglan or Zofran within the 6 hours prior to presentation Exclusion Criteria: Allergy to Reglan, capsaicin or Zofran Another identifiable source for nausea and vomiting (i.e. gastritis, COVID, diabetic ketoacidosis) Molar pregnancies, Patients with a history of gastroparesis Patients with a history of preexisting diabetes mellitus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of 0.075% capsaicin cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS)11,12. The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered. | Drug: Capsaicin Topical Cream<br>* 5g 0.075% applied once<br>Drug: Metoclopramide<br>* 10mg IV once<br>* Other names: Reglan;Drug: Ondansetron<br>* 8mg IV once if needed<br>* Other names: Zofran;Drug: Lactated Ringers, Intravenous<br>* 1000cc once<br>|
| Placebo Comparator: Placebo group<br>Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of placebo cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS). The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered. | Drug: Metoclopramide<br>* 10mg IV once<br>* Other names: Reglan;Drug: Ondansetron<br>* 8mg IV once if needed<br>* Other names: Zofran;Drug: Lactated Ringers, Intravenous<br>* 1000cc once<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to symptom control | Time to perceived symptom control as measured by a validated scale used to measure patient's perception of the severity of nausea and vomiting symptoms (i.e. VAS) | 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of antiemetics needed for symptom control |  | 180 minutes | 
| Length of emergency department stay | Time to discharge from the emergency department | 180 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea, capsaicin, vomiting, pregnancy, hyperemesis gravidarum