1-hour Premedication for Allergy Goal in Emergency: PAGE-1 Study (PAGE1)

February 16, 2026 updated by: Paul Peng, MD PhD MSCR

1-hour Premedication for Allergy Goal in Emergency Computed Tomography, A Randomized Controlled Non-inferiority Trial: PAGE-1 Study

1-hour Premedication for Allergy Goal in Emergency: PAGE-1 is a prospective, parallel, two-arm, non-inferiority, randomized controlled trial evaluating the safety of a 1-hour (intervention) versus a 4-hour (standard regimen) intravenous (IV) premedication protocol in adult patients in the Emergency Department (ED) with a documented iodinated contrast allergy and requiring computed tomography (CT) imaging for a high-risk indication.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Allergic or hypersensitivity reactions to iodinated contrast media are rare, estimated to occur in 0.3% to 1.4% of cases, but have decreased significantly after the switch from high-osmolar to low-osmolar contrast. Most reactions are mild, and breakthrough reactions occur regardless of the timing of premedication. IV premedication is recommended, but there is no level I evidence for its basis in the ED.

This study addresses the sparse evidence that underpins the ubiquitous multi-hour premedication protocols in EDs nationwide. It specifically challenges the existing paradigm of 4-5 hours of IV premedication, which has remarkably never been prospectively validated.

Study Type

Interventional

Enrollment (Estimated)

540

Phase

  • 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 Contact

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult (≥ 21 years old)
  2. Documented iodinated contrast allergy in the electronic health record
  3. CT with iodinated contrast ordered for a high-risk indication, † defined as post-arrest, concern for aortic dissection, ischemia, occlusion, obstruction, or other life-threatening conditions requiring timely diagnosis
  4. Willing and able to give consent

Exclusion Criteria:

  1. Previous enrollment in this study
  2. Pregnancy
  3. Seafood or iodine allergy, alone
  4. Gadolinium allergy

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1-hour Premedication Protocol
IV glucocorticoid and antihistamine 1 hour before contrast
Other: IV glucocorticoid and antihistamine
Methylprednisolone sodium succinate (e.g., Solu-Medrol®) 40 mg IV immediately plus diphenhydramine 25 mg IV 1 hour before contrast medium administration for CT imaging
Active Comparator: 4-hour Premedication Protocol
IV glucocorticoid 4 hours before contrast and IV antihistamine 1 hour before contrast
Other: IV glucocorticoid and antihistamine (standard of care)
Methylprednisolone sodium succinate (e.g., Solu-Medrol®) 40 mg IV immediately 4 hours before contrast medium administration, plus diphenhydramine 25 mg IV 1 hour before contrast for CT imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in proportion of Acute Contrast Reaction
Time Frame: 30 minutes
Measurement of any contrast reaction after contrast administration
30 minutes
Proportion of patients eligible for intervention
Time Frame: Before randomization
Ratio of those eligible to screened
Before randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion randomized to intervention and control
Time Frame: Within 30 minutes after completion of CT imaging
Ratio of patients randomized to intervention and control arms, and who complete the protocol as specified
Within 30 minutes after completion of CT imaging
Adverse events after intervention
Time Frame: Within 30 minutes after assessment of primary outcome
Proportion of patients who required intramuscular epinephrine, noninvasive ventilation, or intubation
Within 30 minutes after assessment of primary outcome

Collaborators and Investigators

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

Sponsor

Paul Peng, MD PhD MSCR

Investigators

  • Principal Investigator: Paul Peng, Rutgers Robert Wood Johnson Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

December 3, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2025002416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol and statistical plan

IPD Sharing Time Frame

Available after start date and 1 year after end of study

IPD Sharing Access Criteria

Study coordinators and key personnel

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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