NCT07268248

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Paul Peng, MD PhD MSCR · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

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

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2025-12-05
• Last updated: 2026-02-19