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

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00783016
First received: October 30, 2008
Last updated: July 25, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Appendicitis
Drug: Morphine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • AUC of ROC of the impression of diagnosis for the appendicitis by surgeon [ Designated as safety issue: No ]

Estimated Enrollment: 234
Study Start Date: October 2008
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Morphine Drug: Morphine
No Intervention: Placebo Drug: Morphine

  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00783016

Locations
Korea, Republic of
Seoul National University Bundang Hospital, Emergency room
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Kyuseok Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00783016     History of Changes
Other Study ID Numbers: KSKim
Study First Received: October 30, 2008
Last Updated: July 25, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
appendicitis
diagnosis

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 28, 2014