Acute Pain ManagementPhase 4NCT01546701
Buprenorphine in Acute Renal Colic Pain Management
A Phase 4 study testing Buprenorphine and Morphine in people with Acute Pain Management and Renal Colic, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether sublingual Buprenorphine is as effective as Iv Morphine sulfate on pain control of the patients with acute renal colic in the emergency department. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Acute Pain Management, Renal Colic
- What is being tested?
- Buprenorphine and Morphine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- Mar 2011to Apr 2012
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinical diagnosis of acute renal colic; positive urinalysis of hematuria; pain score more than 3 in Numerical Rating Score (NRS); patients sign the informed consent to enroll.
Who cannot join
- previous history of seizures; cardiovascular, hepatic, renal or metabolic diseases;
- febrile patients (T > 38°C);
- hemodynamically unstable patients ( Systolic Blood Pressure < 90 mmHg);
- pregnant patients;
- patients with abdominal tenderness as a sign of peritoneal inflammation;
- any clinical suspicion for diseases other than urolithiasis like abdominal aortic aneurysm or dissection;
- patients with a history of drug addiction or known allergy to opioids;
- patients who had used analgesics 6 hours before arriving.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether sublingual Buprenorphine is as effective as Iv Morphine sulfate on pain control of the patients with acute renal colic in the emergency department.
- Conditions
- Acute Pain Management, Renal Colic
- Being tested
- Buprenorphine, Morphine
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
2 mg sublingual tablet
MorphineDrug
0.1 mg/kg IV morphine
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine | Experimental | Renal Colic Patients treated by 2 mg sublingual Buprenorphine. Receives: Drug: Buprenorphine |
| Morphine | Active comparator | Renal Colic Patients treated by 0.1 mg/kg intravenous morphine. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain score
change in pain severity based on Numerical Rating Score
Measured: 20 and 40 minutes
Secondary outcomes (1)
treatment side effects
experiencing any side effects by the patients as a result of treatment protocols.
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMar 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pain ManagementStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Jalili, MD, Study director, TUMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546701
- Sponsor's protocol ID
- 130-1848
- Status last verified
- Dec 2012
- First submitted
- 1 Mar 2012
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buprenorphine in Acute Renal Colic Pain Management
- ClinicalTrials.gov ID
- NCT01546701
- Acronym / sponsor ID
- 130-1848
- Conditions
- Acute Pain Management, Renal Colic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 7 Mar 2012 (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 this study is to determine whether sublingual Buprenorphine is as effective as Iv Morphine sulfate on pain control of the patients with acute renal colic in the emergency department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine | Experimental | Drug: BuprenorphineRenal Colic Patients treated by 2 mg sublingual Buprenorphine. |
| Morphine | Active comparator | Drug: MorphineRenal Colic Patients treated by 0.1 mg/kg intravenous morphine. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- clinical diagnosis of acute renal colic; positive urinalysis of hematuria; pain score more than 3 in Numerical Rating Score (NRS); patients sign the informed consent to enroll.
Key exclusion criteria (8 listed)
- previous history of seizures; cardiovascular, hepatic, renal or metabolic diseases;
- febrile patients (T > 38°C);
- hemodynamically unstable patients ( Systolic Blood Pressure < 90 mmHg);
- pregnant patients;
- patients with abdominal tenderness as a sign of peritoneal inflammation;
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 |
|---|---|---|
| Buprenorphine2 mg sublingual tablet | Drug | Buprenorphine |
| Morphine0.1 mg/kg IV morphine | Drug | Morphine |
Primary outcome
change in pain score
Time frame: 20 and 40 minutes
change in pain severity based on Numerical Rating Score
1 secondary outcome
treatment side effects
Time frame: 40 minutes
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 10 Dec 2012.
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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.
Mohammad Jalili, MD study director
TUMS
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 Buprenorphine and Morphine in people with Acute Pain Management and Renal Colic, 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 1 inclusion and 8 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 10 Dec 2012. 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?
change in pain score (time frame: 20 and 40 minutes). 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 10 Dec 2012.