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25 active trials for Nausea

Inhaled Isopropyl Alcohol Versus Placebo to Manage Nausea at Electronic Dance Music Festivals

BACKGROUND Studies have shown that isopropyl alcohol inhalation is effective for the relief of nausea in the emergency department. A 2016 randomized controlled trial found that nasally inhaled isopropyl alcohol achieved better nausea relief compared to placebo during a 10-minute period. In 2018, another randomized controlled trial showed that nasally inhaled isopropyl alcohol with or without oral ondansetron provided greater relief for nausea than oral ondansetron alone. QUESTION In electronic dance music festival attendees, who present with nausea to the medical team, how does inhaled isopropyl alcohol compare with inhaled sterile saline (placebo) for self-reported nausea 10-minutes post-intervention? METHODS Albertan electronic dance music festival attendees who present with nausea to the medical team, will be recruited until sample size reaches at least 70. Inclusion criteria will be festival attendees aged 18+ with a complaint of nausea. Exclusion criteria will include known allergy to isopropyl alcohol, inability to inhale through the nares, inability to report level of nausea, or already have taken an anti-nauseant. After obtaining consent, participants will be randomized into two study arms. Arm 1 will nasally inhale an isopropyl alcohol pad with 10 deep inhalations (intervention). Arm 2 will nasally inhale a sterile saline pad with 10 deep inhalations (placebo). The pad must be within 2cm from the nares to ensure delivery. According to a study in 2002, isopropyl alcohol pad inhalation, dosed at 3 inhalations every 5 minutes for 3 doses, was not significantly different than standard treatment for relief of nausea. 10 inhalations exceeds the 9-dose total reported in the paper, and a one-time bolus dose of 10 inhalations, for the population and festival context, is more feasible in terms of patient compliance and patient flow. After randomization, participants will rate their nausea on a numeric response scale (0 to 10, where 0 is no nausea and 10 is "worst nausea imaginable"). 10-minutes post-inhalation (isopropyl alcohol or placebo), participants will be asked to rate their nausea again. The primary outcome is self-reported nausea scores 10-minutes post-intervention. The secondary outcome is the presence or absence of any vomiting spells 10-minutes post-intervention, as well as the presence or absence of rescue-medication needed 10-minutes post-intervention.

Start: July 2021

Accupressure of P6 to Reduce Nausea During Cesarean Section

The purpose of this study is to evaluate if the addition of P6 pressure point stimulation as opposed to sham-point stimulation will decrease intraoperative and postoperative nausea and vomiting (IONV and PONV) for patients undergoing non-emergent cesarean delivery. We hypothesize that the addition of stimulation of the P6 pressure point to our institutional current standard of care (phenylephrine infusion, intravenous fluid bolus, and as needed intraoperative ondansetron) will decrease the occurrence of intraoperative emesis.

Start: May 2021

S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis

This phase II trial studies how well isatuximab works in treating patients with primary amyloidosis that has come back or does not respond to treatment. Monoclonal antibodies, such as isatuximab, may interfere with the ability of cancer cells to grow and spread.

Start: March 2018

Vitamin D Deficiency and Dysautonomia

In previous work the investigator identified a group of children between the ages of 10-18 years whose diagnostic workup for chronic nausea unexplained by conventional diagnostic tests has unexpectedly revealed underlying cardiovascular instability manifesting as orthostatic intolerance, primary defined as postural orthostatic tachycardia syndrome (POTS) (88%). While this is an atypical initial presentation for orthostatic intolerance in general, the investigator believes that the cardiovascular problem is serious and represents a cause of the nausea in a majority of these individuals, as treatment of the POTS with fludrocortisone reduced the symptoms of nausea. While fludrocortisone treatment abrogates the fall in baroreflex sensitivity (BRS) during tilt in part, it did not completely correct the tachycardia symptoms or the BRS suppression during HUT. Furthermore it caused an elevation in MAP in supine position, which may lead to future cardiovascular problems such as early onset hypertension and cardiac hypertrophy. This argues for a different treatment approach. The investigator presents preliminary data in this application revealing that OI subjects tend to have lower 25-hydroxy vitamin D (25(OH)D) compared to non OI subjects.

Start: June 2016

Enhanced Recovery Strategies in Elective Breast Surgery

Postoperative pain, nausea, and vomiting are frustrating sequelae of elective breast surgery. Poorly managed postoperative pain can lead to increased opioid use, increased postoperative nausea and vomiting (PONV), delayed return to work and usual activities, unplanned hospital admissions, surgical complications, and patient dissatisfaction. In light of the growing opioid epidemic in the United States, any intervention that potentially minimizes opioid use may have meaningful individual and societal impact. In patients undergoing breast reduction and breast augmentation surgery, multiple techniques for managing postoperative pain are used commonly. One such technique is the use of a paravertebral block (PVB), which is a method of injecting local anesthesia into the area surrounding the spinal nerves in order to decrease sensation and pain in the chests and breasts in the setting of breast surgery. PVB is generally used concomitantly with standard multimodal perioperative pain management including cool compress, non-steroidal anti-inflammatories (NSAIDs), acetaminophen, and opioids. All of these pain management strategies are used at the University of Wisconsin and are considered standard of care for breast surgery nationwide. The overall purpose of this study is to evaluate interventions that aim to optimize pain control, minimize the risk of PONV, and improve recovery after elective breast surgery. We will do this by (1) Comparing PVB with standard pain management strategies in patients undergoing planned breast reduction and breast augmentation, and (2) Comparing "enhanced recovery after surgery" (ERAS) strategies to standard of care for patients undergoing planned breast reduction and breast augmentation. This will be studied using pain assessments, validated surveys, medication logs, and review of medical records.

Start: September 2017

VR to Improve CINV, Sleep and Pain Among Children With Cancer in HK

Chemotherapy-induced nausea and vomiting, sleep quality and pain are the common symptoms experienced by children with cancer. These symptoms significantly devastate the children's quality of life. Hypnosis is found to be effective in managing chemotherapy-induced nausea and vomiting, sleep quality and pain in children with cancer. In addition, virtual reality is shown to promote the effectiveness of hypnosis in managing these symptoms. However, no study so far has examine it effectiveness in Hong Kong Chinese children with cancer. This study aims to investigate the effectiveness in the use a virtual reality device to improve chemotherapy-induced nausea and vomiting, sleep quality and pain among children with cancer in Hong Kong.

Start: September 2021

Study of Hesperidin Therapy on COVID-19 Symptoms (HESPERIDIN)

The main aim of this study is to determine the effects of short-term treatment with hesperidin on COVID-19 symptoms in comparison with a placebo. Treatment effects will be observed through a symptoms diary that will be completed by participants throughout the study and by taking the oral temperature daily.

Start: February 2021

Psychometric Properties of the Chinese Version of PeNAT

Cancer is a leading cause of death for children. Chemotherapy is the most common treatment for cancer. Notwithstanding the improved survival, children with cancer still have to face a significant amount of symptoms associated with chemotherapy. Two major symptoms induced by chemotherapy are nausea and vomiting. These two symptoms were demonstrated to cause serious disruption in patients' daily function and quality of life. Given these devastating impacts, intervening children with appropriate methods to alleviate nausea and vomiting during chemotherapy is therefore crucial. It is imperative for nurses to develop non-pharmacological interventions to reduce nausea and vomiting, with the goal of improving the QoL of children with cancer when undergoing chemotherapy First, however, careful assessment of nausea and vomiting in children with cancer is a necessary step towards designing appropriate interventions. This study aims to translate and validate an instrument (PeNAT) which can assess nausea and vomiting among Hong Kong Chinese children and adolescents undergoing chemotherapy

Start: September 2021

RCT of Olanzapine for Control of CIV in Children Receiving HSCT Conditioning

Chemotherapy-induced nausea and vomiting (CINV) are among the most bothersome symptoms during cancer treatment according to children and their parents. Most children receiving hematopoietic stem cell transplant (HSCT) conditioning experience CINV despite receiving antiemetic prophylaxis. Olanzapine improves CINV control in adult cancer patients, has a track record of safe use in children with psychiatric illness, does not interact with chemotherapy and is inexpensive. We hypothesize that the addition of olanzapine to standard antiemetics will improve chemotherapy-induced vomiting (CIV) control in children receiving chemotherapy for HSCT conditioning.

Start: August 2017

Noninvasive Markers of Functional Nausea in Children

The researchers propose to study how functional nausea in adolescents may be characterized noninvasively by the use of multichannel electrogastrogram (EGG) and magnetogastrogram (MGG) recordings.

Start: August 2018

The BARF Project: A Pilot Study Using the BARF Scale to Assess CINV in Children

In this pilot study, the Baxter Retching Faces (BARF) Scale will be used to assess chemotherapy induced nausea and vomiting (CINV) in the pediatric cancer population during chemotherapy admissions, and the corresponding administration of anti-emetic medications will be reviewed.

Start: March 2021

Cannabis For Cancer-Related Symptoms

Clinical evidence is urgently needed to be able to advise patients on which cannabis-based products to take, or to avoid, in managing cancer-related symptoms. This trial was therefore designed to determine which cannabis extract combination (High THC-Low CBD, Low THC-High CBD, or Equal amounts of THC and CBD) is most effective at treating cancer related symptoms for each patient relative to placebo. Investigators propose a randomized, double-blind, N-of-1 trial to test the effectiveness of each cannabis extract combination using cannabis oils in a minimum of 120 patients on 4 cancer-related symptoms: nausea, pain, anxiety and sleep disturbance. The three active treatments will be the following cannabis oil extract combinations: High THC/Low CBD, Low THC/High CBD, and Equal amounts of THC/CBD. THC = Tetrahydrocannabinol CBD = Cannabidiol The placebo treatment will be coconut/olive oil. The overpowering flavor of the olive oil in the active oils and the placebo will effectively blind subjects. Primary objective: To identify whether there is an active cannabis extract that is more effective than placebo in managing overall cancer-related symptoms for individual subjects who completed at least 1 treatment cycle for the entire patient population represented by those individual subjects, and for subsets of that subject population defined by relevant baseline patient characteristics. Secondary objective: To identify whether there is a cannabis extract that is more effective than placebo in managing each of the 4 index symptoms (pain, nausea, anxiety and sleep disturbance) for individual subjects who completed at least 1 treatment cycle, for the entire patient population represented by those individual subjects, and for subsets of that subject population defined by relevant baseline patient characteristics. Tertiary objectives: To investigate the safety (e.g., serious adverse events) of each of the three cannabis extracts. To identify subject preference of each of the 4 oils (if any).

Start: February 2021

Haloperidol for the Treatment of Nausea and Vomiting in the ED

Single center, double-blind, randomized, controlled trial in patients who present to the emergency department (ED) with a chief complaint of nausea or vomiting. A total of 300 patients age 18-55 presenting to the emergency department with chief complaint of nausea or vomiting will be enrolled from February 2021 - February 2022. Patients will be randomized and symptom levels will be recorded at 30, 60, 90, minutes. Follow-up will be performed by telephone at 24 hours.

Start: April 2021

Value of Ondansetron Medication vs Inhaled Isopropyl Therapy in the Emergency Department (VOMIITED)

This study will compare two different ways to relieve nausea and vomiting in the Emergency Department. The usual treatment for nausea/vomiting is a drug called Zofran, but new studies have suggested that smelling alcohol pads can also help to relieve nausea and vomiting.

Start: July 2017

The Effects of Inhaled Aromatherapy on Chemotherapy Induced Nausea (CINV) and Vomiting

This study is a three group, randomized, double blind, placebo-controlled trial with two repeated measurements. The same measurements will be collected for each participant during two consecutive chemotherapy treatment cycles.Subjects will be provided with written instructions as an educational handout as well as essential oil safety information. Subjects will be able to demonstrate an ability and accurate understanding of the proper use of the diffusers, using a demonstration diffuser, at the time of consent. At the time the subject will provide written informed consent, they will be randomly assigned to one of the three groups with a pocket diffuser containing either ginger essential oil, peppermint essential oil, or vanilla extract )placebo- control). This is based on a pre-determined list of random assignments. Each subject will be instructed to inhale from the pocket diffuser beginning on the day of their chemotherapy (Day 1) and continue using the inhaler for the next three consecutive days (Day 1-Day 4). The subjects will remove the cover of the pocket diffuser, place the pocket diffuser approximately an inch away from their nose and inhale three times with deep breathing (i.e., three sniffs). Subjects will take 3 sniffs of the aromatherapy inhaler three times daily (morning, afternoon, and evening). In addition to the Pre-treatment Assessment, occurring before each of the 2 cycles of chemotherapy, the subjects will be contacted to complete assessments at approximately 24 and 72 hours post-chemotherapy. A member of the study team will call the participant again at their preferred time of day to ask the survey questions. The same procedures will be repeated during the participant's second cycle of chemotherapy, which is likely two or three weeks after the first one.

Start: April 2021

Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer

This randomized phase II/III trial studies how well netupitant and palonosetron hydrochloride works in preventing chronic nausea and vomiting in patients with cancer. Netupitant and palonosetron hydrochloride may reduce nausea and vomiting.

Start: May 2017

The Effect of Cannabidiol on Lean Body Mass in Patients Receiving Chemotherapy

An intervention study on the effect of cannabidiol on lean body mass in cancer patients receiving chemotherapy, at the department of Clinical Oncology at Zealand University Hospital, Roskilde, Denmark. Fat free mass will be measured by bioimpedance spectroscopy. As secondary outcomes protein and energy intake, nausea, taste alterations and life quality will be assessed by oral interviews and questionnaires.

Start: December 2020

A Study of Randomized Sham-control Auricular TENS Unit Stimulation in Pediatric Functional Gastrointestinal Disorders

The purpose of this study is to see if using a micro-current through a device called a TENS (Transcutaneous Electrical Nerve Stimulator) unit helps to improve functional gastrointestinal disorder (FGID) symptoms in children by stimulation of the vagus nerve. The study will compare two methods of stimulation to determine if there is a difference in the two methods.

Start: September 2020

Auriculotherapy and Acupuncture's Treatment for Chemotherapy-induced Nausea and Vomiting (CINV)

The management of chemotherapy-induced nausea and vomiting (CINV) has evolved in recent years and became less frequent. CINV include early (occurring within 24 hours of chemotherapy administration) and delayed (occurring within 4 days after chemotherapy) nausea and vomiting. Preventive treatment, such as Glucocorticoids, 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists and neurokinin 1 (NK1) receptor antagonists, are administered according to the classification in 4 grades of expected CINV Very low: <10% occurrence of CINV; Low: 10 to 30% occurrence of CINV; Average: 30 to 90% occurrence of CINV; High: > 90% occurrence of CINV. These treatments have been the subject of recommendations. Despite these available treatments, some patients still complain of vomiting, or more frequently nausea and loss of appetite. Meanwhile, Chinese acupuncture has proven effective on the prevention of CINV as complementary treatment, mainly in the acute phase and to a lesser extent in the delayed phase. The most common points are Pericardium 6 (wrist) treated with conventional acupuncture needles, electro-acupuncture or acupressure. Auriculotherapy (ear acupuncture) has proven effective on nausea of pregnancy and postoperative nausea, but, to our knowledge, there are no studies published on the effect of auriculotherapy on CINV. These complementary treatments have virtually no side effects. In our institution, a simple treatment of acupuncture (2 points Pericardium 6 treated) and auriculotherapy (2 auricular point treated) is regularly use in patients who present CINV despite preventive treatment and most of them are relieved. The investigators propose a clinical trial in this population to assess symptoms improvement in patients presenting CINV after their first administration of chemotherapy despite adapted preventive treatment. Experimental treatment with semi-permanent needles takes place during administration of the second session of chemotherapy. CINV are evaluated through the (MAT) score that measures the frequency and intensity of nausea and vomiting in the 24 hours following the session and during the 4 days after administration Chemotherapy. Multinational Association of Supportive Care in Cancer Antiemesis Tool (MASCC), Http://www.MASCC.org/.

Start: May 2016

Isopropyl Alcohol Inhalation as Anti-emetic Therapy in the Emergency Department

Nausea and vomiting is a common and distressing presenting complaint in Canadian emergency departments. Commonly used nausea medications have proven to be effective in certain patient populations, for example cancer patients. However, not one has been proven to be more effective that the other in the emergency department setting. In addition, many are associated with significant side effects and have the potential to interact with a patient's home medications. This limits their use in the emergency department until the patient is seen and assessed by their treating physician. Many studies have shown that nasal inhalation of alcohol swabs is an effective therapy in relieving nausea and vomiting in post-operative patients after surgeries. The goal of this study will be to determine the effectiveness of alcohol swabs in the emergency department setting in relieving nausea and vomiting.

Start: July 2020