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

NCT07268248 | Not Yet Recruiting DMC

• 1 other identifier: Pro2025002416
• Study Type: interventional
• Target: 540
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Iodinated Contrast Reaction; Contrast-enhanced CT; Glucocorticoid prophylaxis

Outcome Measures

Primary Outcomes (2)

• Difference in proportion of Acute Contrast Reaction

  Measurement of any contrast reaction after contrast administration

  30 minutes

• Proportion of patients eligible for intervention

  Ratio of those eligible to screened

  Before randomization

Secondary Outcomes (2)

• Proportion randomized to intervention and control

  Within 30 minutes after completion of CT imaging

• Adverse events after intervention

  Within 30 minutes after assessment of primary outcome

Study Arms (2)

1-hour Premedication Protocol

EXPERIMENTAL

IV glucocorticoid and antihistamine 1 hour before contrast

Other: IV glucocorticoid and antihistamine

4-hour Premedication Protocol

ACTIVE COMPARATOR

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

Other: IV glucocorticoid and antihistamine (standard of care)

Interventions

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

4-hour Premedication Protocol

IV glucocorticoid and antihistamine 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

1-hour Premedication Protocol

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous enrollment in this study
• Pregnancy
• Seafood or iodine allergy, alone
• Gadolinium allergy

Sponsors & Collaborators

• Paul Peng, MD PhD MSCR: lead

Related Publications (12)

• Davenport MS, Cohan RH. The Evidence for and Against Corticosteroid Prophylaxis in At-Risk Patients. Radiol Clin North Am. 2017 Mar;55(2):413-421. doi: 10.1016/j.rcl.2016.10.012.

  PMID: 28126223 BACKGROUND

• Greenberger PA, Halwig JM, Patterson R, Wallemark CB. Emergency administration of radiocontrast media in high-risk patients. J Allergy Clin Immunol. 1986 Apr;77(4):630-4. doi: 10.1016/0091-6749(86)90357-x.

  PMID: 3958391 BACKGROUND

• Lasser EC, Berry CC, Talner LB, Santini LC, Lang EK, Gerber FH, Stolberg HO. Pretreatment with corticosteroids to alleviate reactions to intravenous contrast material. N Engl J Med. 1987 Oct 1;317(14):845-9. doi: 10.1056/NEJM198710013171401.

  PMID: 3627208 BACKGROUND

• Katayama H, Yamaguchi K, Kozuka T, Takashima T, Seez P, Matsuura K. Adverse reactions to ionic and nonionic contrast media. A report from the Japanese Committee on the Safety of Contrast Media. Radiology. 1990 Jun;175(3):621-8. doi: 10.1148/radiology.175.3.2343107.

  PMID: 2343107 BACKGROUND

• Amiri E. Optimizing Premedication Strategies for Iodinated Contrast Media in CT scans: A Literature Review. J Med Imaging Radiat Sci. 2025 Jan;56(1):101782. doi: 10.1016/j.jmir.2024.101782. Epub 2024 Nov 20.

  PMID: 39571411 BACKGROUND

• Freed KS, Leder RA, Alexander C, DeLong DM, Kliewer MA. Breakthrough adverse reactions to low-osmolar contrast media after steroid premedication. AJR Am J Roentgenol. 2001 Jun;176(6):1389-92. doi: 10.2214/ajr.176.6.1761389.

  PMID: 11373198 BACKGROUND

• Mervak BM, Davenport MS, Ellis JH, Cohan RH. Rates of Breakthrough Reactions in Inpatients at High Risk Receiving Premedication Before Contrast-Enhanced CT. AJR Am J Roentgenol. 2015 Jul;205(1):77-84. doi: 10.2214/AJR.14.13810.

  PMID: 26102383 BACKGROUND

• Mervak BM, Cohan RH, Ellis JH, Khalatbari S, Davenport MS. Intravenous Corticosteroid Premedication Administered 5 Hours before CT Compared with a Traditional 13-Hour Oral Regimen. Radiology. 2017 Nov;285(2):425-433. doi: 10.1148/radiol.2017170107. Epub 2017 Jul 26.

  PMID: 28745940 BACKGROUND

• Wang CL, Cohan RH, Ellis JH, Caoili EM, Wang G, Francis IR. Frequency, outcome, and appropriateness of treatment of nonionic iodinated contrast media reactions. AJR Am J Roentgenol. 2008 Aug;191(2):409-15. doi: 10.2214/AJR.07.3421.

  PMID: 18647910 BACKGROUND

• Goldfarb JW. National trends in contrast media enhanced and unenhanced computed tomography use. Clin Imaging. 2023 Jan;93:103-105. doi: 10.1016/j.clinimag.2022.11.009. Epub 2022 Nov 17. No abstract available.

  PMID: 36427426 BACKGROUND

• Berlyand Y, Fraga JA, Succi MD, Yun BJ, Lee AH, Baugh JJ, Whitehead D, Raja AS, Prabhakar AM. Impact of iodinated contrast allergies on emergency department operations. Am J Emerg Med. 2022 Nov;61:127-130. doi: 10.1016/j.ajem.2022.08.052. Epub 2022 Sep 5.

  PMID: 36096014 BACKGROUND

• Wang C, Ramsey A, Lang D, Maria Copaescu A, Krishnan P, Kuruvilla M, Mervak B, Newhouse J, Sumkin A, Saff R. Management and Prevention of Hypersensitivity Reactions to Radiocontrast Media: A Consensus Statement from the American College of Radiology and the American Academy of Allergy, Asthma & Immunology. Radiology. 2025 May;315(2):e240100. doi: 10.1148/radiol.240100.

  PMID: 40326871 BACKGROUND

MeSH Terms

Conditions

Hypersensitivity

Interventions

Glucocorticoids; Histamine Antagonists; Standard of Care

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Paul Peng

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chirag N Shah, MD

CONTACT

732-235-8717; shahcn@rwjms.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 5, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Available after start date and 1 year after end of study
• Access Criteria: Study coordinators and key personnel