CT Scan Using IV Contrast Alone for Pediatric Appendicitis

NCT00716703 | Completed

• 1 other identifier: RSRB9986
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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. SPECIFIC AIMS

1. 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. 2.To determine test performance characteristics (specificity, sensitivity and diagnostic accuracy) of CT IV in detecting appendicitis in children.

Conditions

Appendicitis; Child; Contrast Media

Keywords

Appendicitis; Computed tomography; pediatric; child; sensitivity; specificity; contrast administration route; time factors

Outcome Measures

Primary Outcomes (1)

• Sensitivity, Specificity, PPV, NPV for CT Scan with IV contrast alone

  Study completion date

Secondary Outcomes (1)

• Time to CT scan for CT with IV contrast alone v. CT using both IV and oral contrast

  study completion date

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

CT Scan using IV contrast alone OTHER

CT scan using IV contrast alone

1

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Appendicitis; Hypersensitivity

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Immune System Diseases

Study Officials

• Madelyn Garcia, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Lynn Babcock-Cimpello, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2008
• First Posted: July 16, 2008
• Study Start: November 1, 2003
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: July 16, 2008

Record last verified: 2008-07

Locations

US (1)