NCT07523230

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2026

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 4, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

AntiemeticNauseaEmergency DepartmentTimingPatient ComfortSymptom Management

Outcome Measures

Primary Outcomes (1)

  • Change in Nausea Severity

    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 Outcomes (1)

  • Comfort Level

    Baseline (T0) and 60 minutes (Tpost60)

Study Arms (2)

Early Antiemetic Group

EXPERIMENTAL

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

Delayed Antiemetic Group

EXPERIMENTAL

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

Interventions

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.

Delayed Antiemetic GroupEarly Antiemetic Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University Hospital, Emergency Department

Istanbul, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NauseaEmergencies

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Muzeyyen Ataseven, PhD,RN

    Istanbul Medipol University, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors were blinded to group allocation to reduce assessment bias. Participants and care providers were aware of the intervention due to the nature of the study, as antiemetic timing could not be concealed.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study is designed as a randomized parallel-group trial in which participants are assigned to either an early or delayed antiemetic administration group. The early group receives antiemetic treatment within 30 minutes of triage (T0), while the delayed group receives treatment after 30 minutes. Outcome measures include nausea severity assessed at baseline (T0), 30 minutes (Tpost30), and 60 minutes (Tpost60) using a Numeric Rating Scale (NRS), and comfort level assessed at baseline and 60 minutes using the General Comfort Questionnaire-Short Form.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD, RN, Assistant Professor

Study Record Dates

First Submitted

April 4, 2026

First Posted

April 13, 2026

Study Start

February 5, 2026

Primary Completion

April 5, 2026

Study Completion

April 5, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations