AppendicitisPhase 4NCT00783016
Effect of Pain Control on the Diagnosis of Acute Appendicitis on the Diagnostic Accuracy of General Surgeon
A Phase 4 study testing Morphine in people with Appendicitis, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2008to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- the patients suspected of acute appendicitis over 15 years
Who cannot join
- less than 15 years
- pregnant
- allergic to morphine
- systolic blood pressure<100mmHg
- received pain killer prior to ED visit
- do not consent
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital, Emergency room
Seongnam-si, Gyeonggi-do, 463-707
About this study
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.
- Conditions
- Appendicitis
- Being tested
- Morphine
- Keywords
- appendicitis, diagnosis
- Medical subject headings
- Appendicitis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Experimental | Not described Receives: Drug: Morphine |
| Placebo | No intervention | Not described Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of ROC of the impression of diagnosis for the appendicitis by surgeon
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783016
- Sponsor's protocol ID
- KSKim
- Status last verified
- Jul 2011
- First submitted
- 30 Oct 2008
- Last updated
- 26 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pain Control on the Diagnosis of Acute Appendicitis on the Diagnostic Accuracy of General Surgeon
- ClinicalTrials.gov ID
- NCT00783016
- Acronym / sponsor ID
- KSKim
- Conditions
- Appendicitis
- Keywords
- appendicitis, diagnosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine | Experimental | Drug: Morphine |
| Placebo | No intervention | Drug: Morphine |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- the patients suspected of acute appendicitis over 15 years
Key exclusion criteria (6 listed)
- less than 15 years
- pregnant
- allergic to morphine
- systolic blood pressure<100mmHg
- received pain killer prior to ED visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine | Drug | Morphine, Placebo |
Primary outcome
AUC of ROC of the impression of diagnosis for the appendicitis by surgeon
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
Related trials for Appendicitis
RecruitingObservational study
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PAINED: Project Addressing INequities in the Emergency Department
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
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Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine in people with Appendicitis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of ROC of the impression of diagnosis for the appendicitis by surgeon. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2011.