AppendicitisPhase 4NCT00477061
Morphine Analgesia in Patients With Acute Appendicitis
A Phase 4 study testing Morphine in people with Appendicitis, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of the study is to evaluate morphine effect on pain reduction and diagnostic accuracy in patients admitted to emergency ward with the diagnosis of acute appendicitis. Read more about this study
- Who is it for?
- Ages 13 to 75 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- Morphine
- How many people
- 71 participants
- Where
- 1 siteIran
- Study dates
- Jan 2004to Mar 2005
- 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 13 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- clinical signs of acute appendicitis
- planned for appendectomy
- supposed to wait for at least 1 hour in the ED before operation
Who cannot join
- suspicion to perforated appendicitis
- being under the age of 13
- pregnancy (according to history and ß-HCG result)
- opium addiction
- systolic blood pressure of less than 90 mmHG
- known cases of chronic obstructive pulmonary disease (COPD)
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- known sensitivity to morphine
- history of sickle cell disease
- self administration of analgesics before enrollment
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind Randomized Study of Morphine Analgesia in Patients With Acute Appendicitis
The purpose of the study is to evaluate morphine effect on pain reduction and diagnostic accuracy in patients admitted to emergency ward with the diagnosis of acute appendicitis.
Read the detailed description
Analgesic administration for pain control in patients with acute abdominal pain, regarding acute appendicitis, is controversial. Despite the results previous studies indicating the safeness of analgesic use in ED for acute abdominal pain, physicians still prefer to postpone their use after performing surgical evaluations. Since many patients admitted to ED are unlikely to receive prompt surgical consultation, many of them need pain relief to prevent unnecessary suffering. On the other hand such pain relief must not interfere with the diagnosis and treatment of patients and do not cause any complications. Morphine is a common and effective analgesic which, if shown to have no effect on correct diagnosis of acute abdomen, can be used for this purpose.
Thus we evaluated morphine effect on pain reduction and diagnostic accuracy in patients admitted to ED with the diagnosis of acute appendicitis.
- Conditions
- Appendicitis
- Being tested
- Morphine
- Keywords
- MORPHINE, ANALGESIA, ACUTE APPENDICITS
- Medical subject headings
- Appendicitis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Secondary outcomes (1)
Diagnostic Accuracy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startJan 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Asieh Golozar, MD, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477061
- Sponsor's protocol ID
- AG11
- Status last verified
- May 2007
- First submitted
- 20 May 2007
- Last updated
- 22 May 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Amoli HA, Golozar A, Keshavarzi S, Tavakoli H, Yaghoobi A. Morphine analgesia in patients with acute appendicitis: a randomised double-blind clinical trial. Emerg Med J. 2008 Sep;25(9):586-9. doi: 10.1136/emj.2007.050914.
PubMed 18723709
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Study of Morphine Analgesia in Patients With Acute Appendicitis
- ClinicalTrials.gov ID
- NCT00477061
- Acronym / sponsor ID
- AG11
- Conditions
- Appendicitis
- Keywords
- MORPHINE, ANALGESIA, ACUTE APPENDICITS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Mar 2005 (actual)
- First posted
- 22 May 2007 (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 purpose of the study is to evaluate morphine effect on pain reduction and diagnostic accuracy in patients admitted to emergency ward with the diagnosis of acute appendicitis.
Detailed description
Analgesic administration for pain control in patients with acute abdominal pain, regarding acute appendicitis, is controversial. Despite the results previous studies indicating the safeness of analgesic use in ED for acute abdominal pain, physicians still prefer to postpone their use after performing surgical evaluations. Since many patients admitted to ED are unlikely to receive prompt surgical consultation, many of them need pain relief to prevent unnecessary suffering. On the other hand such pain relief must not interfere with the diagnosis and treatment of patients and do not cause any complications. Morphine is a common and effective analgesic which, if shown to have no effect on correct diagnosis of acute abdomen, can be used for this purpose.
Thus we evaluated morphine effect on pain reduction and diagnostic accuracy in patients admitted to ED with the diagnosis of acute appendicitis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 13 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- clinical signs of acute appendicitis
- planned for appendectomy
- supposed to wait for at least 1 hour in the ED before operation
Key exclusion criteria (10 listed)
- suspicion to perforated appendicitis
- being under the age of 13
- pregnancy (according to history and ß-HCG result)
- opium addiction
- systolic blood pressure of less than 90 mmHG
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 | – |
Primary outcome
Pain Intensity
1 secondary outcome
Diagnostic Accuracy
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 22 May 2007.
- Derived from this study: PubMed 18723709Amoli HA, Golozar A, Keshavarzi S, Tavakoli H, Yaghoobi A. Morphine analgesia in patients with acute appendicitis: a randomised double-blind clinical trial. Emerg Med J. 2008 Sep;25(9):586-9. doi: 10.1136/emj.2007.050914.
Related trials for Appendicitis
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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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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.
Asieh Golozar, MD principal investigator
Tehran University of Medical Sciences
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 Tehran University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 10 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 22 May 2007. 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 Iran. 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?
Pain Intensity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00477061, which also lists 1 linked publication.
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 22 May 2007.