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

ConditionsAllergic Reaction to Contrast MediaHypersensitivity ReactionComputed TomographyPremedication
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorPaul Peng, MD PhD MSCR

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Previous enrollment in this study

Pregnancy

Seafood or iodine allergy, alone

Gadolinium allergy

Trial design

Design model

Parallel

Treatments tested in this trial

  • IV glucocorticoid and antihistamine

    Other intervention

    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 intervention

    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

Treatment groups

540 Participants
are divided into 2 treatment groups
Group A: 1-hour Premedication ProtocolExperimental treatment 1 intervention
Group B: 4-hour Premedication ProtocolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Difference in proportion of Acute Contrast Reaction

Measurement of any contrast reaction after contrast administration

Time frame
30 minutes
2

Proportion of patients eligible for intervention

Ratio of those eligible to screened

Time frame
Before randomization

Secondary outcomes

1

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
2

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Paul Peng, MD PhD MSCR

Lead sponsor

Rutgers, The State University of New Jersey

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: