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

NCT ID: NCT07268248

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 426 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-30
• Study Completion Date: 2028-06-30

Brief Summary

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1-hour Premedication Protocol

IV glucocorticoid and antihistamine 1 hour before contrast

Group Type: EXPERIMENTAL

IV glucocorticoid and antihistamine

Intervention Type: 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

4-hour Premedication Protocol

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

Group Type: ACTIVE_COMPARATOR

IV glucocorticoid and antihistamine (standard of care)

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paul Peng, MD PhD MSCR

OTHER

Sponsor Role: lead

Responsible Party

Paul Peng, MD PhD MSCR

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paul Peng

Role: PRINCIPAL_INVESTIGATOR

Rutgers Robert Wood Johnson Medical School

Central Contacts

Chirag N Shah, MD

Role: CONTACT

shahcn@rwjms.rutgers.edu

732-235-8717

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

Pro2025002416

Identifier Type: -

Identifier Source: org_study_id