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

Paul Peng, MD PhD MSCR

Status: Begins enrollment in 3 months

Conditions: Premedication; Computed Tomography; Allergic Reaction to Contrast Media; Hypersensitivity Reaction

Treatments: Other: IV glucocorticoid and antihistamine; Other: IV glucocorticoid and antihistamine (standard of care)

Study type: Interventional

Funder types: Other

Identifiers

NCT07268248

Pro2025002416

Details and patient eligibility

About

1-hour Premedication for Allergy Goal in Emergency: PAGE-1 is a prospective, parallel, two-arm, non-inferiority, multicenter 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.

Full 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.

Enrollment: 426 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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426 participants in 2 patient groups

1-hour Premedication Protocol

Experimental group

Description:

IV glucocorticoid and antihistamine 1 hour before contrast

Treatment:

Other: IV glucocorticoid and antihistamine

4-hour Premedication Protocol

Active Comparator group

Description:

IV glucocorticoid 4 hours before contrast and IV antihistamine 1 hour before contrast

Treatment:

Other: IV glucocorticoid and antihistamine (standard of care)