- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07523230
Effect of Antiemetic Timing on Nausea Severity and Patient Comfort in the Emergency Department (ANTI-ED)
The Effect of Antiemetic Timing on Nausea Severity and Patient Comfort in the Emergency Department: A Multicenter Interventional Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye), 34810
- Istanbul Medipol University Hospital, Emergency Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Nausea Severity
Time Frame: Baseline (T0), 30 minutes (Tpost30), and 60 minutes (Tpost60)
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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.
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Baseline (T0), 30 minutes (Tpost30), and 60 minutes (Tpost60)
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Secondary Outcome Measures
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.
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Baseline (T0) and 60 minutes (Tpost60)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muzeyyen Ataseven, PhD,RN, Istanbul Medipol University, Faculty of Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ED-ANTIMETIC-TIMING
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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