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

Primary Purpose

Appendicitis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Morphine
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Appendicitis focused on measuring appendicitis, diagnosis

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital, Emergency room

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Morphine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

AUC of ROC of the impression of diagnosis for the appendicitis by surgeon

Secondary Outcome Measures

Full Information

First Posted
October 30, 2008
Last Updated
July 25, 2011
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00783016
Brief Title
Effect of Pain Control on the Diagnosis of Acute Appendicitis on the Diagnostic Accuracy of General Surgeon
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
appendicitis, diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Morphine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Morphine
Primary Outcome Measure Information:
Title
AUC of ROC of the impression of diagnosis for the appendicitis by surgeon

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Bundang Hospital, Emergency room
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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