NCT00783016CompletedPhase 4
Effect of Pain Control on the Diagnosis of Acute Appendicitis on the Diagnostic Accuracy of General Surgeon
Seoul National University Hospital1 site in 1 country234 target enrollmentStarted: October 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 234
- Locations
- 1
- Primary Endpoint
- AUC of ROC of the impression of diagnosis for the appendicitis by surgeon
Study Overview
Brief Summary
The pain control in surgical abdomen has been in debate in masking the correct diagnosis. We would like to investigate the effect of pain control on the diagnostic accuracy of surgeon in suspicious appendicitis patients.
We would give morphine or placebo to the patients suspected of appendicitis randomly and in double-blinded manner, and then surgeons would exam the patient and give the impression for the possibility of the appendicitis(grading 1 to 4).
With this grading, we compare these impression between two groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to 90 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •the patients suspected of acute appendicitis over 15 years
Exclusion Criteria
- •less than 15 years
- •allergic to morphine
- •systolic blood pressure<100mmHg
- •received pain killer prior to ED visit
- •do not consent
Arms & Interventions
Morphine
Experimental
Intervention: Morphine (Drug)
Placebo
No Intervention
Intervention: Morphine (Drug)
Outcomes
Primary Outcomes
AUC of ROC of the impression of diagnosis for the appendicitis by surgeon
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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