Renal ColicPhase 4NCT01543165
Efficacy of Nefopam and Morphine in Balanced Analgesia for Acute Ureteric Colic
A Phase 4 study testing Ketorolac and nefopam balanced analgesia and Balanced analgesia using ketorolac and morphine in people with Renal Colic, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is to see whether the combination regimen of ketorolac and nefopam is superior to that of ketorolac and morphine in controlling ureter stone-related acute flank pain. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Renal Colic
- What is being tested?
- Ketorolac and nefopam balanced analgesia and Balanced analgesia using ketorolac and morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to Dec 2013
- 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
- Acute flank with visual analog pain scale score equal or more than 5
- and most possible diagnosis after initial clinical exam is acute renal colic
Who cannot join
- Pregnant or lactating women
- Patients whose use of any of the study drugs is contraindicated
- Patients with documented renal or hepatic failure or those with clinical findings suggesting the diagnoses
- Recent episode of acute myocardial infarction or patients with significant heart failure
- Patients with documented gastric/duodenal ulcer or those with clinical findings suggesting the diagnoses
- Patients with bleeding tendency
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- Patients who have history of any seizure
- Patients with documented organic brain injury
- Patients taking warfarin
- Patients whose primary diagnosis is not renal colic
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Kyeongi-do
Kyuseok Kim, MD, 82-31-787-3049, dremkks@snubh.org
Joonghee Kim, MD, 82-10-9489-3696, joonghee@me.com
About this study
Official title: A Single Center, Prospective Randomized Double-blind Trial: Efficacy of Nefopam and Morphine in Balanced Analgesia for Acute Ureteric Colic
This study is to see whether the combination regimen of ketorolac and nefopam is superior to that of ketorolac and morphine in controlling ureter stone-related acute flank pain.
Read the detailed description
The balanced analgesia regimen using both ketorolac and morphine is the most effective choice in controlling urolithiasis related acute pain. Previous animal and human studies reported that combination regimen of ketoprofen and nefopam showed synergistic effect in pain control. We hypothesized that using nefopam instead of morphine for ketorolac based combination analgesia will produce similar pain reduction without causing opioid-related side effect.
- Conditions
- Renal Colic
- Being tested
- Ketorolac and nefopam balanced analgesia, Balanced analgesia using ketorolac and morphine, Pain control with single analgesics (ketorolac)
- Keywords
- Renal colic, Analgesia, Nefopam, Ketorolac
- 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.
Ketorolac and nefopam balanced analgesiaDrug
Sequential intravenous administration of ketorolac and nefopam
Balanced analgesia using ketorolac and morphineDrug
Sequential intravenous administration of ketorolac and morphine
Pain control with single analgesics (ketorolac)Drug
This arm do not use balanced analgesia. Instead, ketorolac IV administration followed by 50cc normal saline administration (for blinding) will be used in this group.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Sequential intravenous administration of ketorolac and nefopam Receives: Drug: Ketorolac and nefopam balanced analgesia |
| Group 2 | Active comparator | Sequential intravenous administration of ketorolac and morphine Receives: Drug: Balanced analgesia using ketorolac and morphine |
| Group 3 | Placebo comparator | Intravenous administration of ketorolac Receives: Drug: Pain control with single analgesics (ketorolac) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of pain reduction by visual analog pain scale
Measured: At 30 and 60 minutes after primary study drug administration
Secondary outcomes (1)
Additional analgesia requested by enrolled patients
Measured: At 30 and 60 minutes after primary study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ColicStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmbio Korea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543165
- Sponsor's protocol ID
- B-1112/141-011
- Status last verified
- Dec 2012
- First submitted
- 27 Feb 2012
- Last updated
- 17 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Prospective Randomized Double-blind Trial: Efficacy of Nefopam and Morphine in Balanced Analgesia for Acute Ureteric Colic
- ClinicalTrials.gov ID
- NCT01543165
- Acronym / sponsor ID
- B-1112/141-011
- Conditions
- Renal Colic
- Keywords
- Renal colic, Analgesia, Nefopam, Ketorolac
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Pharmbio Korea
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 2 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.
This study is to see whether the combination regimen of ketorolac and nefopam is superior to that of ketorolac and morphine in controlling ureter stone-related acute flank pain.
Detailed description
The balanced analgesia regimen using both ketorolac and morphine is the most effective choice in controlling urolithiasis related acute pain. Previous animal and human studies reported that combination regimen of ketoprofen and nefopam showed synergistic effect in pain control. We hypothesized that using nefopam instead of morphine for ketorolac based combination analgesia will produce similar pain reduction without causing opioid-related side effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Ketorolac and nefopam balanced analgesiaSequential intravenous administration of ketorolac and nefopam |
| Group 2 | Active comparator | Drug: Balanced analgesia using ketorolac and morphineSequential intravenous administration of ketorolac and morphine |
| Group 3 | Placebo comparator | Drug: Pain control with single analgesics (ketorolac)Intravenous administration of ketorolac |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Acute flank with visual analog pain scale score equal or more than 5
- and most possible diagnosis after initial clinical exam is acute renal colic
Key exclusion criteria (10 listed)
- Pregnant or lactating women
- Patients whose use of any of the study drugs is contraindicated
- Patients with documented renal or hepatic failure or those with clinical findings suggesting the diagnoses
- Recent episode of acute myocardial infarction or patients with significant heart failure
- Patients with documented gastric/duodenal ulcer or those with clinical findings suggesting the diagnoses
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 |
|---|---|---|
| Ketorolac and nefopam balanced analgesiaSequential intravenous administration of ketorolac and nefopam | Drug | Group 1 |
| Balanced analgesia using ketorolac and morphineSequential intravenous administration of ketorolac and morphine | Drug | Group 2 |
| Pain control with single analgesics (ketorolac)This arm do not use balanced analgesia. Instead, ketorolac IV administration followed by 50cc normal saline administration (for blinding) will be used in this group. | Drug | Group 3 |
Primary outcome
Amount of pain reduction by visual analog pain scale
Time frame: At 30 and 60 minutes after primary study drug administration
1 secondary outcome
Additional analgesia requested by enrolled patients
Time frame: At 30 and 60 minutes after primary study drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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.
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 Ketorolac and nefopam balanced analgesia and Balanced analgesia using ketorolac and morphine in people with Renal Colic, 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 2 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: status not confirmed, as of the sponsor's last update on 17 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 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyuseok Kim, MD (82-31-787-3049, dremkks@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of pain reduction by visual analog pain scale (time frame: At 30 and 60 minutes after primary study drug administration). 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 17 Dec 2012.