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

Women and Infants Hospital of Rhode Island

Status and phase: Completed; Phase 2

Conditions: Nausea Gravidarum; Hyperemesis Gravidarum; Vomiting of Pregnancy

Treatments: Drug: Metoclopramide; Drug: Lactated Ringers, Intravenous; Drug: Capsaicin Topical Cream; Drug: Ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT05098067

1763191-1

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

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.

Treatment:

Drug: Ondansetron

Drug: Lactated Ringers, Intravenous

Drug: Capsaicin Topical Cream

Drug: Metoclopramide

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Ondansetron

Drug: Lactated Ringers, Intravenous

Drug: Metoclopramide