Renal ColicPhase 4NCT03137498
Lidocaine vs Ketorolac for Management of Renal Colic in the Emergency Department
A Phase 4 study testing Lidocaine and Ketorolac in people with Renal Colic, run by The Brooklyn Hospital Center at 1 site in United States.
Trial summary
The hypothesis of the study is that lidocaine will be as effective as ketorolac in decreasing patient's perception of pain as measured by the 10 point Visual Analogue Scale (VAS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Colic
- What is being tested?
- Lidocaine and Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2017to 6 Mar 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years old and older
- Presenting with acute generalized pain secondary to suspected or confirmed renal colic
- Describes pain to be greater than or equal to 3 out of 10 on the numeric rating scale (NRS)
- Provides informed consent.
Who cannot join
- Reported/documented allergy to lidocaine OR ketorolac (Toradol) OR morphine, corn, aspirin, ibuprofen
- Patients who are hemodynamically unstable as dictated by the medical resident or attending [(Heart rate not within 60-110bpm); (Respiratory rate not within 12-20 bpm); (Blood pressure not within 90/50 to 180/100); (Oxygen saturation not within 94-100%)]
- Patient with unwillingness to provide informed consent
- Patients with past medical history of cardiovascular disorders (examples include but are not limited to: myocardial infarction, ischemic heart disease, atrial fibrillation, heart blocks, Wolff-Parkinson-White syndrome, slow heart rate, bradycardia, coronary artery disease, QT prolongation)
- Past medical history of: liver dysfunction (ie: cirrhosis), chronic alcohol abuse, gastrointestinal bleed or recent gastrointestinal bleed (within past 5 days), renal dysfunction or disease, seizures (or currently actively receiving treatment for seizures), inflammatory bowel disease (or currently actively receiving treatment for inflammatory bowel disease), hepatitis (or currently actively receiving treatment for hepatitis).
- History of liver transplant
Show all 14Show fewer
- Currently on dialysis
- Has acute heart, kidney, liver, respiratory failure or trauma
- In altered mental status
- In significant trauma, actively breastfeeding or pregnant
- Has language barriers who are unable to describe pain,
- Weighing at or over 130kg
- Has a blood pressure reading greater than 180/120 mmHg at triage,
- Previously enrolled to the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Brooklyn Hospital Center
Brooklyn, New York, 11201
Billy W Sin, Pharm.D., 718-250-6250
Michael Hochberg, MD, 718-250-6202
About this study
Official title: Lidocaine Versus Ketorolac for the Management of Renal Colic
The hypothesis of the study is that lidocaine will be as effective as ketorolac in decreasing patient's perception of pain as measured by the 10 point Visual Analogue Scale (VAS). The aim of the study is to compare the safety \& efficacy of lidocaine versus ketorolac for acute pain secondary to renal colic in the Emergency Department (ED).
Read the detailed description
The hypothesis of the study is that lidocaine will be as effective as ketorolac in decreasing patient's perception of pain as measured by the 10 point Visual Analogue Scale (VAS). The aim of the study is to compare the safety \& efficacy of lidocaine versus ketorolac for acute pain secondary to renal colic in the Emergency Department (ED). The primary endpoint is patient's perception of pain as described by the use of numeric rating scale (NRS) at 15 minutes after initial study interventions. The secondary endpoints are incidence of adverse events during the study period, patient perception of pain as described by the use of NRS at 0, 5, 15, 30, 45, 60, 75, 90 minutes after initial administration of study interventions, frequency and mean dose of rescue analgesic therapy needed at 0, 5, 15, 30, 45, 60, 75, 90 minutes, incidence of adverse events such as but would not be limited to: dizziness, perioral numbness, nausea, vomiting, arrhythmia [examples could be but are not limited to: atrial fibrillation, ventricular tachycardia, ventricular fibrillation), hypotension (≤90/60 mmHg), flushing, headache, tremors, ear pain, injection site reactions, disorientation, respiratory depression (respiratory rate less than 12bpm), oxygen saturation less than 90%)], the number of bedside ultrasounds for diagnosis conducted, the number of CT scans for diagnosis conducted, result of radiologic imaging (Ultrasound / Computerized Tomography), time to patient discharge from the initiation of study medication/placebo, patient satisfaction of pain control based on a Likert Scale, the number of patients who consumed an adjuvant pain medication for analgesia.
- Conditions
- Renal Colic
- Keywords
- renal colic, lidocaine, ketorolac, acute pain
- Medical subject headings
- Renal Colic, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Prilocaine
Lidocaine 1.5mg/kg IVPB in 50ml normal saline over 10 minutes x 1dose
KetorolacDrug
Also called Toradol
Ketorolac 30mg (1ml) intravenous push injection x 1dose
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Lidocaine 1.5mg/kg IVPB in 50ml normal saline over 10 minutes (active experimental) and normal saline 1ml intravenous push injection (placebo) Receives: Drug: Lidocaine |
| Ketorolac | Active comparator | Ketorolac 30mg (1ml) intravenous push injection (active intervention) and Normal saline 50ml IVPB over 10 minutes (placebo) Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score at 15 minutes
Patient's perception of pain as described by the use of numeric rating scale (NRS) at 15 minutes after initial study interventions
Measured: at 15 minutes after initial study interventions
Secondary outcomes (16)
Adverse event-dizziness
incidence of dizziness throughout
Measured: throughout study period (90 minutes)
Adverse event-perioral numbness
incidence of perioral numbness
Measured: throughout study period (90 minutes)
Adverse event-nausea
incidence of nausea
Measured: throughout study period (90 minutes)
Adverse event-vomiting
incidence of vomiting
Measured: throughout study period (90 minutes)
Adverse event-arrhythmia
incidence of arrhythmia (atrial fibrillation, ventricular tachycardia, ventricular fibrillation)
Measured: throughout study period (90 minutes)
Adverse event-hypotension
incidence of hypotension (≤90/60 mmHg)
Measured: throughout study period (90 minutes)
Adverse event-flushing
incidence of flushing
Measured: throughout study period (90 minutes)
Adverse event-headache
incidence of headache
Measured: throughout study period (90 minutes)
Adverse event-tremors
incidence of tremors
Measured: throughout study period (90 minutes)
Adverse event-ear pain
incidence of ear pain
Measured: throughout study period (90 minutes)
Adverse event-injection site reactions
incidence of injection site reactions
Measured: throughout study period (90 minutes)
Adverse event-disorientation
incidence of disorientation
Measured: throughout study period (90 minutes)
Adverse event-respiratory depression
incidence of respiratory depression (respiratory rate less than 12bpm)
Measured: throughout study period (90 minutes)
Adverse event-oxygen saturation less than 90%
incidence of oxygen saturation less than 90%
Measured: throughout study period (90 minutes)
patient satisfaction of pain control based on a Likert Scale
based on a Likert Scale
Measured: throughout study period (90 minutes)
the number of patients who consumed an adjuvant pain medication for analgesia.
the number of patients who consumed an adjuvant pain medication for analgesia.
Measured: throughout study period (90 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start6 Mar 2017
- Primary completion6 Mar 2019 (estimated)
- Study completion6 Mar 2019 (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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Brooklyn Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie de Souza, MD, Study chair, The Brooklyn Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137498
- Sponsor's protocol ID
- 902683
- Status last verified
- Jul 2018
- First submitted
- 6 Mar 2017
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Versus Ketorolac for the Management of Renal Colic
- ClinicalTrials.gov ID
- NCT03137498
- Acronym / sponsor ID
- 902683
- Conditions
- Renal Colic
- Keywords
- renal colic, lidocaine, ketorolac, acute pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Brooklyn Hospital CenterUniversity, hospital or other
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 6 Mar 2019 (estimated)
- Study completion
- 6 Mar 2019 (estimated)
- First posted
- 2 May 2017 (actual)
- 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 hypothesis of the study is that lidocaine will be as effective as ketorolac in decreasing patient's perception of pain as measured by the 10 point Visual Analogue Scale (VAS). The aim of the study is to compare the safety \& efficacy of lidocaine versus ketorolac for acute pain secondary to renal colic in the Emergency Department (ED).
Detailed description
The hypothesis of the study is that lidocaine will be as effective as ketorolac in decreasing patient's perception of pain as measured by the 10 point Visual Analogue Scale (VAS). The aim of the study is to compare the safety \& efficacy of lidocaine versus ketorolac for acute pain secondary to renal colic in the Emergency Department (ED). The primary endpoint is patient's perception of pain as described by the use of numeric rating scale (NRS) at 15 minutes after initial study interventions. The secondary endpoints are incidence of adverse events during the study period, patient perception of pain as described by the use of NRS at 0, 5, 15, 30, 45, 60, 75, 90 minutes after initial administration of study interventions, frequency and mean dose of rescue analgesic therapy needed at 0, 5, 15, 30, 45, 60, 75, 90 minutes, incidence of adverse events such as but would not be limited to: dizziness, perioral numbness, nausea, vomiting, arrhythmia [examples could be but are not limited to: atrial fibrillation, ventricular tachycardia, ventricular fibrillation), hypotension (≤90/60 mmHg), flushing, headache, tremors, ear pain, injection site reactions, disorientation, respiratory depression (respiratory rate less than 12bpm), oxygen saturation less than 90%)], the number of bedside ultrasounds for diagnosis conducted, the number of CT scans for diagnosis conducted, result of radiologic imaging (Ultrasound / Computerized Tomography), time to patient discharge from the initiation of study medication/placebo, patient satisfaction of pain control based on a Likert Scale, the number of patients who consumed an adjuvant pain medication for analgesia.
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 |
|---|---|---|
| Lidocaine | Experimental | Drug: LidocaineLidocaine 1.5mg/kg IVPB in 50ml normal saline over 10 minutes (active experimental) and normal saline 1ml intravenous push injection (placebo) |
| Ketorolac | Active comparator | Drug: KetorolacKetorolac 30mg (1ml) intravenous push injection (active intervention) and Normal saline 50ml IVPB over 10 minutes (placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years old and older
- Presenting with acute generalized pain secondary to suspected or confirmed renal colic
- Describes pain to be greater than or equal to 3 out of 10 on the numeric rating scale (NRS)
- Provides informed consent.
Key exclusion criteria (14 listed)
- Reported/documented allergy to lidocaine OR ketorolac (Toradol) OR morphine, corn, aspirin, ibuprofen
- Patients who are hemodynamically unstable as dictated by the medical resident or attending [(Heart rate not within 60-110bpm); (Respiratory rate not within 12-20 bpm); (Blood pressure not within 90/50 to 180/100); (Oxygen saturation not within 94-100%)]
- Patient with unwillingness to provide informed consent
- Patients with past medical history of cardiovascular disorders (examples include but are not limited to: myocardial infarction, ischemic heart disease, atrial fibrillation, heart blocks, Wolff-Parkinson-White syndrome, slow heart rate, bradycardia, coronary artery disease, QT prolongation)
- Past medical history of: liver dysfunction (ie: cirrhosis), chronic alcohol abuse, gastrointestinal bleed or recent gastrointestinal bleed (within past 5 days), renal dysfunction or disease, seizures (or currently actively receiving treatment for seizures), inflammatory bowel disease (or currently actively receiving treatment for inflammatory bowel disease), hepatitis (or currently actively receiving treatment for hepatitis).
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 |
|---|---|---|
| LidocaineAlso: PrilocaineLidocaine 1.5mg/kg IVPB in 50ml normal saline over 10 minutes x 1dose | Drug | Lidocaine |
| KetorolacAlso: ToradolKetorolac 30mg (1ml) intravenous push injection x 1dose | Drug | Ketorolac |
Primary outcome
Pain score at 15 minutes
Time frame: at 15 minutes after initial study interventions
Patient's perception of pain as described by the use of numeric rating scale (NRS) at 15 minutes after initial study interventions
16 secondary outcomes
Adverse event-dizziness
Time frame: throughout study period (90 minutes)
Adverse event-perioral numbness
Time frame: throughout study period (90 minutes)
Adverse event-nausea
Time frame: throughout study period (90 minutes)
Adverse event-vomiting
Time frame: throughout study period (90 minutes)
Adverse event-arrhythmia
Time frame: throughout study period (90 minutes)
Adverse event-hypotension
Time frame: throughout study period (90 minutes)
Adverse event-flushing
Time frame: throughout study period (90 minutes)
Adverse event-headache
Time frame: throughout study period (90 minutes)
Adverse event-tremors
Time frame: throughout study period (90 minutes)
Adverse event-ear pain
Time frame: throughout study period (90 minutes)
Adverse event-injection site reactions
Time frame: throughout study period (90 minutes)
Adverse event-disorientation
Time frame: throughout study period (90 minutes)
Adverse event-respiratory depression
Time frame: throughout study period (90 minutes)
Adverse event-oxygen saturation less than 90%
Time frame: throughout study period (90 minutes)
patient satisfaction of pain control based on a Likert Scale
Time frame: throughout study period (90 minutes)
the number of patients who consumed an adjuvant pain medication for analgesia.
Time frame: throughout study period (90 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Renal Colic
RecruitingPhase 3
Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the ED
Renal Colic
Not yet recruiting
Relief Efficacy of Lidocaine Versus Morphine for Acute Renal Colic in the Emergency Department
Renal Colic, Kidney Stones, Urolithiasis, Hypocitraturia
Recruiting
Ear Pressure Points Plus Pain Meds for Faster Kidney Stone Pain Relief
Renal Colic, Acupuncture, Ear
Active, not recruiting
Sterile Water Injection vs Morphine for Renal Colic
Renal Colic, Urolithiasis
Not yet recruitingPhase 4
Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation and Dexketoprofen in Renal Colic
Renal Colic
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.
Sylvie de Souza, MD study chair
The Brooklyn Hospital Center
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 Lidocaine and Ketorolac in people with Renal Colic, run by The Brooklyn Hospital Center at 1 site in United States.
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 4 inclusion and 14 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 11 Jul 2018. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Billy Sin, PharmD (718-250-6250, bsin@tbh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score at 15 minutes (time frame: at 15 minutes after initial study interventions). 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 11 Jul 2018.