NCT00783016

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 26, 2011

Status Verified

July 1, 2011

Enrollment Period

2.3 years

First QC Date

October 30, 2008

Last Update Submit

July 25, 2011

Conditions

Appendicitis

Keywords

appendicitisdiagnosis

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

Morphine

EXPERIMENTAL
Drug: Morphine

Placebo

NO INTERVENTION
Drug: Morphine

Interventions

MorphineDRUG
MorphinePlacebo

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • the patients suspected of acute appendicitis over 15 years

You may not qualify if:

  • less than 15 years
  • pregnant
  • allergic to morphine
  • systolic blood pressure\<100mmHg
  • received pain killer prior to ED visit
  • do not consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital, Emergency room

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

AppendicitisDisease

Interventions

Morphine

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 30, 2008

First Posted

October 31, 2008

Study Start

October 1, 2008

Primary Completion

February 1, 2011

Study Completion

May 1, 2011

Last Updated

July 26, 2011

Record last verified: 2011-07

Locations

KR(1)