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NCT Number: NCT07268248

1-hour Premedication for Allergy Goal in Emergency: 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.

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Key information

Conditions

Allergic Reaction to Contrast Media Computed Tomography Hypersensitivity Hypersensitivity Reaction Immune System Diseases Premedication

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (≥ 21 years old)
  • Documented iodinated contrast allergy in the electronic health record
  • 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
  • Willing and able to give consent

Exclusion criteria

  • Previous enrollment in this study
  • Pregnancy
  • Seafood or iodine allergy, alone
  • Gadolinium allergy

Treatment and study plan

IV glucocorticoid and antihistamine

Other

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

IV glucocorticoid and antihistamine (standard of care)

Other

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

Primary outcomes

  1. Difference in proportion of Acute Contrast Reaction

    Time frame: 30 minutes

    Measurement of any contrast reaction after contrast administration

  2. Proportion of patients eligible for intervention

    Time frame: Before randomization

    Ratio of those eligible to screened

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chirag N Shah, MD

CONTACT

[email protected]

732-235-8717

Sponsors and collaborators

Lead sponsor

Paul Peng, MD PhD MSCR

Other

Registry information

Official study title

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

Acronym: PAGE1

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 5, 2025
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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