Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Intervention group 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
5g 0.075% applied once
Drug: Metoclopramide
10mg IV once
Other Names:
Drug: Ondansetron
8mg IV once if needed
Other Names:
Drug: Lactated Ringers, Intravenous
1000cc once
|
Placebo Comparator: Placebo group 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
10mg IV once
Other Names:
Drug: Ondansetron
8mg IV once if needed
Other Names:
Drug: Lactated Ringers, Intravenous
1000cc once
|
Outcome Measures
Primary Outcome Measures
- Time to symptom control [180 minutes]
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)
Secondary Outcome Measures
- Number of antiemetics needed for symptom control [180 minutes]
- Length of emergency department stay [180 minutes]
Time to discharge from the emergency department
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pregnant women in the first trimester (0-14 weeks gestation)
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Presenting to the emergency room at Women & Infants Hospital in Rhode Island with a chief complaint of nausea and vomiting
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English or Spanish speaking
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Have not taken an anti-emetic such as Reglan or Zofran within the 6 hours prior to presentation
Exclusion Criteria:
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Allergy to Reglan, capsaicin or Zofran
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Another identifiable source for nausea and vomiting (i.e. gastritis, COVID, diabetic ketoacidosis)
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Molar pregnancies,
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Patients with a history of gastroparesis
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Patients with a history of preexisting diabetes mellitus
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Women and Infants Hospital of Rhode Island
Investigators
- Principal Investigator: Lauren Murphy, MD, Women and Infants Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
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- Dean DJ, Sabagha N, Rose K, Weiss A, France J, Asmar T, Rammal JA, Beyer M, Bussa R, Ross J, Chaudhry K, Smoot T, Wilson K, Miller J. A Pilot Trial of Topical Capsaicin Cream for Treatment of Cannabinoid Hyperemesis Syndrome. Acad Emerg Med. 2020 Nov;27(11):1166-1172. doi: 10.1111/acem.14062. Epub 2020 Jul 20.
- Gazmararian JA, Petersen R, Jamieson DJ, Schild L, Adams MM, Deshpande AD, Franks AL. Hospitalizations during pregnancy among managed care enrollees. Obstet Gynecol. 2002 Jul;100(1):94-100.
- Piwko C, Koren G, Babashov V, Vicente C, Einarson TR. Economic burden of nausea and vomiting of pregnancy in the USA. J Popul Ther Clin Pharmacol. 2013;20(2):e149-60. Epub 2013 Jul 10.
- Richards JR, Lapoint JM, Burillo-Putze G. Cannabinoid hyperemesis syndrome: potential mechanisms for the benefit of capsaicin and hot water hydrotherapy in treatment. Clin Toxicol (Phila). 2018 Jan;56(1):15-24. doi: 10.1080/15563650.2017.1349910. Epub 2017 Jul 21.
- Yosipovitch G, Mengesha Y, Facliaru D, David M. Topical capsaicin for the treatment of acute lipodermatosclerosis and lobular panniculitis. J Dermatolog Treat. 2005 Aug;16(3):178-80.
- Yuan LJ, Qin Y, Wang L, Zeng Y, Chang H, Wang J, Wang B, Wan J, Chen SH, Zhang QY, Zhu JD, Zhou Y, Mi MT. Capsaicin-containing chili improved postprandial hyperglycemia, hyperinsulinemia, and fasting lipid disorders in women with gestational diabetes mellitus and lowered the incidence of large-for-gestational-age newborns. Clin Nutr. 2016 Apr;35(2):388-393. doi: 10.1016/j.clnu.2015.02.011. Epub 2015 Mar 2.
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