Acute Renal ColicNCT01339624
Nasal Fentanyl And Renal Colic
A study testing FENTANYL and Ketorolac Tromethamine AND morphine in people with Acute Renal Colic, run by Valduce Hospital at 1 site in Italy.
Trial summary
The purpose of this study is to determine whether nasal fentanyl is effective in the treatment of renal colic in adults in emergency department. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Renal Colic
- What is being tested?
- FENTANYL and Ketorolac Tromethamine AND morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2009to Sep 2009
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients were adults aged 18 to 65 years, presenting in ED with classical clinical symptoms of renal colic (sudden monolateral flank pain with inguinal irradiation) with a 10-cm visual analog scale (VAS) greater than or equal to 7
Who cannot join
- Were analgesia within 6 hours of arrival
- Allergy to opiates and NSAIDs
- Opiates abuse, known or suspected abdominal aortic dissection or aneurism,
- Presence of peritonitis
- Hemodynamic instability
- Pregnancy, breastfeeding, anticoagulant therapy.
- Patients with known renal, pulmonary, cardiac or hepatic failure, as well as those with renal transplantation, were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether nasal fentanyl is effective in the treatment of renal colic in adults in emergency department.
- Conditions
- Acute Renal Colic
- Being tested
- FENTANYL, Ketorolac Tromethamine AND morphine
- Keywords
- analgesia, renal colic, ketorolac, nasal fentanyl, morphine., treatment of acute renal colic
- Medical subject headings
- Renal Colic, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FENTANYLDrug
FENTANYL CITRATE, NASAL, 3 GAMMA/KG
Ketorolac Tromethamine AND morphineDrug
morphine 5 MG diluted in saline solution 100 ml followed by 2-ml ampoule of ketorolac 30 MG in saline solution 100 ml was infused:
| Study group | Role | What they receive |
|---|---|---|
| NASAL FENTANYL, | Active comparator | Not described Receives: Drug: FENTANYL |
| KETOROLAC + MORPHINE | Active comparator | Not described Receives: Drug: Ketorolac Tromethamine AND morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual analogue scale pain intensity score
This measure was obtained using a 10-cm with marked numbers visual analog scale (VAS score).
Measured: 30 and 60 minutes
Secondary outcomes (2)
Use of rescue therapy at 30 minutes
Measured: 30 MINUTES
The occurrence of adverse events
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal ColicStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339624
- Sponsor's protocol ID
- NASAL FENTANYL-01
- Status last verified
- Sep 2009
- First submitted
- 15 Apr 2011
- Last updated
- 20 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Fentanyl And Renal Colic
- ClinicalTrials.gov ID
- NCT01339624
- Acronym / sponsor ID
- NASAL FENTANYL-01
- Conditions
- Acute Renal Colic
- Keywords
- analgesia, renal colic, ketorolac, nasal fentanyl, morphine., treatment of acute renal colic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 Apr 2011 (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 nasal fentanyl is effective in the treatment of renal colic in adults in emergency department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NASAL FENTANYL, | Active comparator | Drug: FENTANYL |
| KETOROLAC + MORPHINE | Active comparator | Drug: Ketorolac Tromethamine AND morphine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients were adults aged 18 to 65 years, presenting in ED with classical clinical symptoms of renal colic (sudden monolateral flank pain with inguinal irradiation) with a 10-cm visual analog scale (VAS) greater than or equal to 7
Key exclusion criteria (7 listed)
- Were analgesia within 6 hours of arrival
- Allergy to opiates and NSAIDs
- Opiates abuse, known or suspected abdominal aortic dissection or aneurism,
- Presence of peritonitis
- Hemodynamic instability
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 |
|---|---|---|
| FENTANYLFENTANYL CITRATE, NASAL, 3 GAMMA/KG | Drug | NASAL FENTANYL, |
| Ketorolac Tromethamine AND morphinemorphine 5 MG diluted in saline solution 100 ml followed by 2-ml ampoule of ketorolac 30 MG in saline solution 100 ml was infused: | Drug | KETOROLAC + MORPHINE |
Primary outcome
Change in visual analogue scale pain intensity score
Time frame: 30 and 60 minutes
This measure was obtained using a 10-cm with marked numbers visual analog scale (VAS score).
2 secondary outcomes
Use of rescue therapy at 30 minutes
Time frame: 30 MINUTES
The occurrence of adverse events
Time frame: 60 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 20 Apr 2011.
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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 study testing FENTANYL and Ketorolac Tromethamine AND morphine in people with Acute Renal Colic, run by Valduce Hospital at 1 site in Italy.
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 7 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 20 Apr 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 Italy. 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.
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 visual analogue scale pain intensity score (time frame: 30 and 60 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 20 Apr 2011.