Effect of Pain Control on the Diagnosis of Acute Appendicitis on the Diagnostic Accuracy of General Surgeon

Appendicitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783016
• Other study ID #: KSKim
• Status: Completed
• Phase: Phase 4
• First received: October 30, 2008
• Last updated: July 25, 2011
• Start date: October 2008
• Est. completion date: May 2011

Study information

• Verified date: July 2011
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: May 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 90 Years

Eligibility

Inclusion Criteria:

• the patients suspected of acute appendicitis over 15 years

Exclusion Criteria:

• less than 15 years

• pregnant

• allergic to morphine

• systolic blood pressure<100mmHg

• received pain killer prior to ED visit

• do not consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Appendicitis

Intervention

Drug:
• Morphine

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital, Emergency room	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of ROC of the impression of diagnosis for the appendicitis by surgeon			No