Effect of Antiemetic Timing on Nausea Severity and Patient Comfort in the Emergency Department (ANTI-ED)

April 22, 2026 updated by: muzeyyen ataseven

The Effect of Antiemetic Timing on Nausea Severity and Patient Comfort in the Emergency Department: A Multicenter Interventional Study

Nausea is a common symptom among patients presenting to the emergency department and can negatively affect patient comfort and clinical outcomes. The timing of antiemetic administration may play a critical role in symptom control; however, evidence regarding the optimal timing remains limited. This multicenter interventional study aims to evaluate the effect of early versus delayed antiemetic administration on nausea severity and patient comfort in adult emergency department patients. Participants will be assigned to receive antiemetic treatment either within the first 30 minutes after triage or after 30 minutes. Nausea severity will be assessed using a numeric rating scale, and patient comfort will be evaluated at predefined time points. The findings of this study are expected to contribute to improving symptom management and optimizing clinical practices in emergency care settings.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Nausea is a frequently encountered symptom in emergency department (ED) patients and is associated with decreased patient comfort, prolonged ED stay, and reduced satisfaction with care. Timely management of nausea is essential for improving patient outcomes; however, there is limited evidence regarding the impact of antiemetic administration timing on symptom relief and patient comfort. This study is designed as a prospective, multicenter interventional study to evaluate the effect of antiemetic timing on nausea severity and patient comfort in adult ED patients.

Eligible participants will include adult patients presenting to the ED with nausea. Participants will be allocated into two groups based on the timing of antiemetic administration: early administration (within 30 minutes after triage) and delayed administration (after 30 minutes). Antiemetic agents will be administered according to standard clinical practice.

The primary outcome of the study is nausea severity, which will be measured using a validated numeric rating scale. Secondary outcomes include patient comfort levels and changes in nausea over time. Measurements will be obtained at baseline and at predefined time intervals following antiemetic administration.

This study aims to provide evidence on whether early administration of antiemetic therapy leads to improved symptom control and patient comfort compared to delayed administration. The results may inform clinical decision-making and contribute to the development of evidence-based protocols for nausea management in emergency settings.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34810
        • Istanbul Medipol University Hospital, Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Presentation to the emergency department with nausea (with or without vomiting)
  • Receiving antiemetic treatment
  • Ability to communicate
  • Ability to provide informed consent
  • Ability to undergo nausea assessment using a Numeric Rating Scale (NRS) at initial evaluation

Exclusion Criteria:

  • Altered level of consciousness (unconscious or confused)
  • Intubated patients
  • Severe psychiatric conditions (e.g., psychosis or delirium)
  • Patients in critical condition requiring immediate resuscitation
  • Hemodynamic instability
  • Inability to communicate (including language barrier or severe hearing/speech impairment preventing scale application)
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Early Antiemetic Group
Participants receive routine antiemetic treatment within 30 minutes after triage (T0). Nausea severity is assessed using a Numeric Rating Scale (NRS, 0-10) at baseline (T0), 30 minutes (Tpost30), and 60 minutes (Tpost60). Comfort level is evaluated at baseline and 60 minutes using the General Comfort Questionnaire-Short Form.
Behavioral: Antiemetic Timing
The intervention consists of adjusting the timing of routine antiemetic administration in emergency department patients without altering the type or dosage of medication. Participants are assigned to receive antiemetics either within 30 minutes (early group) or after 30 minutes (delayed group) following triage (T0), in accordance with standard clinical care. Outcome measures include nausea severity assessed using a Numeric Rating Scale (NRS, 0-10) at T0, Tpost30, and Tpost60, and comfort level assessed at T0 and Tpost60.
Experimental: Delayed Antiemetic Group
Participants receive routine antiemetic treatment more than 30 minutes after triage (T0). Nausea severity is assessed using a Numeric Rating Scale (NRS, 0-10) at baseline (T0), 30 minutes (Tpost30), and 60 minutes (Tpost60). Comfort level is evaluated at baseline and 60 minutes using the General Comfort Questionnaire-Short Form.
Behavioral: Antiemetic Timing
The intervention consists of adjusting the timing of routine antiemetic administration in emergency department patients without altering the type or dosage of medication. Participants are assigned to receive antiemetics either within 30 minutes (early group) or after 30 minutes (delayed group) following triage (T0), in accordance with standard clinical care. Outcome measures include nausea severity assessed using a Numeric Rating Scale (NRS, 0-10) at T0, Tpost30, and Tpost60, and comfort level assessed at T0 and Tpost60.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Nausea Severity
Time Frame: Baseline (T0), 30 minutes (Tpost30), and 60 minutes (Tpost60)
Nausea severity will be assessed using a Numeric Rating Scale (NRS, 0-10). Measurements will be obtained at baseline (T0), 30 minutes (Tpost30), and 60 minutes (Tpost60). The primary outcome is the change in nausea severity over time between the early and delayed antiemetic groups.
Baseline (T0), 30 minutes (Tpost30), and 60 minutes (Tpost60)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comfort Level
Time Frame: Baseline (T0) and 60 minutes (Tpost60)
Comfort level will be assessed using the General Comfort Questionnaire-Short Form. Measurements will be obtained at baseline (T0) and 60 minutes (Tpost60). Differences between groups will be analyzed.
Baseline (T0) and 60 minutes (Tpost60)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
muzeyyen ataseven

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Müzeyyen Ataseven, PhD,RN, Istanbul Medipol University, Faculty of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ED-ANTIMETIC-TIMING

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy and ethical considerations. De-identified data may be available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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