Renal ColicPhase 4NCT02782273
Morphine Versus Ketorolac in Renal Colic
A Phase 4 study testing Ketorolac and Morphine in people with Renal Colic, run by Loredana Ghinea.
Trial summary
The study is prospective, double blinded, randomised controlled and has the purpose to compare the analgesic effects of ketorolac or morphine intravenous in renal colic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Colic
- What is being tested?
- Ketorolac and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Sep 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of renal colic
- grade 5 pain on a 1-10 visual pain scale
Who cannot join
- contraindications of ketorolac or opioids
- pregnancy
- allergies to ketorolac or opioids
- refusal of participation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Analgesic Effects of Morphine Versus Ketorolac in Renal Colic
The study is prospective, double blinded, randomised controlled and has the purpose to compare the analgesic effects of ketorolac or morphine intravenous in renal colic.
Read the detailed description
The study will take place in the Emergency Department of the Clinical Emergency Hospital Bucharest and will compare the analgesic effects of ketorolac tromethamine against morphine in renal colic.
The patients will be randomised to receive either ketorolac 30 mg intravenous (diluted in 20 ml of 0,9% saline) or morphine 0,1 mg/kg weight intravenous. A scale of 1-10 will be used for measuring the pain, and the effects of the treatment will be evaluated at 15 minutes and 30 minutes from the administration of the drugs. After 30 minutes if there is no significant reduction of the pain a rescue therapy will be used : chlorhydrate drotaverine 40 mg, xilocaine 100 mg, both diluted in 100 ml saline and the other medication not used from the study (morphine or ketorolac tromethamine).
- Conditions
- Renal Colic
- Keywords
- ketorolac, pain relieve, 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.
KetorolacDrug
The patients randomised to this arm they will receive 30 mg intravenous ketorolac.
MorphineDrug
The patients randomised to this arm they will receive 0,1 mg/kg intravenous morphine.
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac | Active comparator | The patients randomised to this arm they will receive 30 mg intravenous ketorolac. Receives: Drug: Morphine |
| Morphine | Active comparator | The patients randomised to this arm they will receive 0,1 mg/kg intravenous morphine. Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reducing the grade of pain
To see the reducing of the pain on a scale 1-10 at two time points
Measured: 15 minutes, 30 minutes
Secondary outcomes (5)
Time of staying in emergency department
Measured: 30 minutes, 1 hour, 2 hours
The necessity of urology consult - interventional measures
The patients will be called after 7 days to see if they needed urology consult and urological intervention
Measured: 7 days
The cost of each treatment
To evaluate the costs of treatment of each type of drug and/or rescue therapy
Measured: 1 hour
The necessity to use rescue therapy - pain > 5 grade
30 minutes from presentation in the ED - if the pain is still > 5 on a 1-10 scale
Measured: 30 minutes
Side effects of each treatment
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (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.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loredana Ghinea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Loredana Ghinea, Bucharest Emergency Hospital
- Investigators
- Dan Marinescu, MD, Principal investigator, Clinical Emergency Hospital Bucharest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782273
- Sponsor's protocol ID
- 1-4627
- Status last verified
- May 2016
- First submitted
- 16 May 2016
- Last updated
- 25 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effects of Morphine Versus Ketorolac in Renal Colic
- ClinicalTrials.gov ID
- NCT02782273
- Acronym / sponsor ID
- 1-4627
- Conditions
- Renal Colic
- Keywords
- ketorolac, pain relieve, morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Loredana GhineaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 25 May 2016 (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 study is prospective, double blinded, randomised controlled and has the purpose to compare the analgesic effects of ketorolac or morphine intravenous in renal colic.
Detailed description
The study will take place in the Emergency Department of the Clinical Emergency Hospital Bucharest and will compare the analgesic effects of ketorolac tromethamine against morphine in renal colic.
The patients will be randomised to receive either ketorolac 30 mg intravenous (diluted in 20 ml of 0,9% saline) or morphine 0,1 mg/kg weight intravenous. A scale of 1-10 will be used for measuring the pain, and the effects of the treatment will be evaluated at 15 minutes and 30 minutes from the administration of the drugs. After 30 minutes if there is no significant reduction of the pain a rescue therapy will be used : chlorhydrate drotaverine 40 mg, xilocaine 100 mg, both diluted in 100 ml saline and the other medication not used from the study (morphine or ketorolac tromethamine).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac | Active comparator | Drug: MorphineThe patients randomised to this arm they will receive 30 mg intravenous ketorolac. |
| Morphine | Active comparator | Drug: KetorolacThe patients randomised to this arm they will receive 0,1 mg/kg intravenous morphine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of renal colic
- grade 5 pain on a 1-10 visual pain scale
Key exclusion criteria (4 listed)
- contraindications of ketorolac or opioids
- pregnancy
- allergies to ketorolac or opioids
- refusal of participation
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 |
|---|---|---|
| KetorolacThe patients randomised to this arm they will receive 30 mg intravenous ketorolac. | Drug | Morphine |
| MorphineThe patients randomised to this arm they will receive 0,1 mg/kg intravenous morphine. | Drug | Ketorolac |
Primary outcome
Reducing the grade of pain
Time frame: 15 minutes, 30 minutes
To see the reducing of the pain on a scale 1-10 at two time points
5 secondary outcomes
Time of staying in emergency department
Time frame: 30 minutes, 1 hour, 2 hours
The necessity of urology consult - interventional measures
Time frame: 7 days
The cost of each treatment
Time frame: 1 hour
The necessity to use rescue therapy - pain > 5 grade
Time frame: 30 minutes
Side effects of each treatment
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
- Individual participant dataSharing planned: Undecided
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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.
Dan Marinescu, MD principal investigator
Clinical Emergency Hospital Bucharest
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac and Morphine in people with Renal Colic, run by Loredana Ghinea.
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 4 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 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Marinescu, MD (0040741020848, danvmarinescu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reducing the grade of pain (time frame: 15 minutes, 30 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 25 May 2016.