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

N/ANot Yet RecruitingNCT07268248

Paul Peng, MD PhD MSCR426 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

426

Conditions

Allergic Reaction to Contrast Media Hypersensitivity Reaction

Interventions

IV glucocorticoid and antihistamineOTHER

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Difference in proportion of Acute Contrast Reaction

Measurement of any contrast reaction after contrast administration

Time frame: 30 minutes

Proportion of patients eligible for intervention

Ratio of those eligible to screened

Time frame: Before randomization

Secondary Outcomes

Proportion randomized to intervention and control

Ratio of patients randomized to intervention and control arms, and who complete the protocol as specified

Time frame: Within 30 minutes after completion of CT imaging

Adverse events after intervention

Proportion of patients who required intramuscular epinephrine, noninvasive ventilation, or intubation

Time frame: Within 30 minutes after assessment of primary outcome