Effect of Pain Control on the Diagnosis of Acute Appendic... | NCT00783016

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

NCT00783016

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jul 26, 2011Estimated

Enrollment

234Estimated

Phase

Phase 4

Conditions

Appendicitis

Interventions

Morphine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Feb 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Oct 30, 2008

First Submission Date that Met QC Criteria

Oct 30, 2008

First Posted Date

Oct 31, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2011

Last Update Posted Date

Jul 26, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

234Estimated

Label	Type	Description	Intervention Names
Morphine	Experimental		Drug: Morphine
Placebo	No Intervention		Drug: Morphine

Name	Type	Description	Arm Group Labels	Other Names
Morphine	Drug		Morphine Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
AUC of ROC of the impression of diagnosis for the appendicitis by surgeon

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital, Emergency room		Seongnam-si	Gyeonggi-do	463-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001064	Appendicitis
D004194	Disease

Ancestor Terms

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009020	Morphine

Ancestor Terms

ID	Term
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided