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

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ClinicalTrials.gov Identifier: NCT00783016
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : July 26, 2011
Sponsor:
Information provided by:
Seoul National University Hospital

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.


Condition or disease Intervention/treatment Phase
Appendicitis Drug: Morphine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Study Start Date : October 2008
Primary Completion Date : February 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Morphine Drug: Morphine
No Intervention: Placebo Drug: Morphine



Primary Outcome Measures :
  1. AUC of ROC of the impression of diagnosis for the appendicitis by surgeon


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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kyuseok Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00783016     History of Changes
Other Study ID Numbers: KSKim
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011

Keywords provided by Seoul National University Hospital:
appendicitis
diagnosis

Additional relevant MeSH terms:
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents