CT Scan Using IV Contrast Alone for Pediatric Appendicitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00716703
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : July 16, 2008
Information provided by:
University of Rochester

Brief Summary:

Computed tomography (CT) scan using intravenous contrast (CT IV) as the sole type of contrast material, was studied as one method of evaluating children with suspected appendicitis. We felt that this technique could provide physicians with a faster and better-tolerated alternative to CT imaging which involves patients drinking oral contrast or needing rectal contrast administered.


  1. To test an imaging protocol using CT IV for the evaluation of suspected appendicitis in children in the setting of a pediatric emergency department (ED).
  2. To determine test performance characteristics (specificity, sensitivity and diagnostic accuracy) of CT IV in detecting appendicitis in children.

Condition or disease Intervention/treatment
Appendicitis Child Contrast Media Other: CT Scan using IV contrast alone

Detailed Description:

This was to be a prospective cohort study imaging pediatric patients (3-18 years old) in whom the diagnosis of appendicitis was suspected, but not clinically apparent. Patients that were to have a CT performed would be invited to participate and if enrolled, would be imaged using CT scan with IV contrast alone.

CT scans would be interpreted in real time by a resident radiologist and/or an attending radiologist. ED evaluation would remain unchanged and patient disposition would be based on the discretion of the ED provider using all information (patient exam, labs, surgical consultation as needed and the results of the CT scan).

CT scan performance would be determined by comparison of the CT interpretation with patient final outcomes as determined by either (1) pathology reports - in patients that went on to have surgery (appendectomy) or (2) clinical phone follow up at 24 hrs and then 1 week after ED discharge.

Performance of CT would be compared between the resident and the attending radiologists.

Further, we would compare the time to obtain a CT scan (defined as ED triage time - Time to CT) between our study cohort and a retrospective cohort of patients who had received CT scan in the ED for evaluation of appendicitis pre-study (CT using BOTH IV and oral contrast).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: CT Scan Using IV Contrast Alone for Pediatric Appendicitis
Study Start Date : November 2003
Primary Completion Date : October 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
cohort = pediatric patients in the ED (3-18 yo) with abdominal pain suspicious for appendicitis that are to undergo CT scan
Other: CT Scan using IV contrast alone
CT scan using IV contrast alone

Primary Outcome Measures :
  1. Sensitivity, Specificity, PPV, NPV for CT Scan with IV contrast alone [ Time Frame: Study completion date ]

Secondary Outcome Measures :
  1. Time to CT scan for CT with IV contrast alone v. CT using both IV and oral contrast [ Time Frame: study completion date ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 3- 18 years
  • Signs/symptoms for < 72 hours
  • CT Scan requested for evaluation by attending or fellow

Exclusion Criteria:

  • Clinically apparent appendicitis
  • Pregnancy
  • Sickle Cell Disease
  • Known contrast allergy
  • Previous enrollment
  • Signs/symptoms for > 72 hrs
  • Known abdominal disease (e.g. Crohn's)
  • Exam unreliable (neurologically impaired patient)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00716703

United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Principal Investigator: Madelyn Garcia, MD, MPH University of Rochester
Principal Investigator: Lynn Babcock-Cimpello, MD University of Rochester

Responsible Party: Madelyn Garcia, MD, MPH, University of Rochester, Dept of Emergency Medicine Identifier: NCT00716703     History of Changes
Other Study ID Numbers: RSRB9986
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: July 16, 2008
Last Verified: July 2008

Keywords provided by University of Rochester:
Computed tomography
contrast administration route
time factors

Additional relevant MeSH terms:
Intraabdominal Infections
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases