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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | Lidocaine 1.5mg/kg IVPB in 50ml normal saline over 10 minutes (active experimental) and normal saline 1ml intravenous push injection (placebo) |
|
| Ketorolac | Active Comparator | Ketorolac 30mg (1ml) intravenous push injection (active intervention) and Normal saline 50ml IVPB over 10 minutes (placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Lidocaine 1.5mg/kg IVPB in 50ml normal saline over 10 minutes x 1dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 15 minutes after initial study interventions |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event-dizziness | incidence of dizziness throughout | throughout study period (90 minutes) |
| Adverse event-perioral numbness | incidence of perioral numbness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Billy Sin, PharmD | Contact | 718-250-6250 | bsin@tbh.org |
| Name | Affiliation | Role |
|---|---|---|
| Sylvie de Souza, MD | The Brooklyn Hospital Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Brooklyn Hospital Center | Recruiting | Brooklyn | New York | 11201 | United States |
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| ID | Term |
|---|---|
| D056844 | Renal Colic |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D011318 | Prilocaine |
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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This is a double-blind placebo-controlled randomized trial where blinding will be conducted and applied to the study investigator, physicians, and nursing staff providing care to the patient. An independent biostatistician will conduct a statistical analysis with blinded data. Only the pharmacists preparing the study interventions will be unblended to the study treatments. The pharmacists procuring the interventions will not be part of data collection or analysis.
| Ketorolac | Drug | Ketorolac 30mg (1ml) intravenous push injection x 1dose |
|
|
| throughout study period (90 minutes) |
| Adverse event-nausea | incidence of nausea | throughout study period (90 minutes) |
| Adverse event-vomiting | incidence of vomiting | throughout study period (90 minutes) |
| Adverse event-arrhythmia | incidence of arrhythmia (atrial fibrillation, ventricular tachycardia, ventricular fibrillation) | throughout study period (90 minutes) |
| Adverse event-hypotension | incidence of hypotension (≤90/60 mmHg) | throughout study period (90 minutes) |
| Adverse event-flushing | incidence of flushing | throughout study period (90 minutes) |
| Adverse event-headache | incidence of headache | throughout study period (90 minutes) |
| Adverse event-tremors | incidence of tremors | throughout study period (90 minutes) |
| Adverse event-ear pain | incidence of ear pain | throughout study period (90 minutes) |
| Adverse event-injection site reactions | incidence of injection site reactions | throughout study period (90 minutes) |
| Adverse event-disorientation | incidence of disorientation | throughout study period (90 minutes) |
| Adverse event-respiratory depression | incidence of respiratory depression (respiratory rate less than 12bpm) | throughout study period (90 minutes) |
| Adverse event-oxygen saturation less than 90% | incidence of oxygen saturation less than 90% | throughout study period (90 minutes) |
| patient satisfaction of pain control based on a Likert Scale | based on a Likert Scale | 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. | throughout study period (90 minutes) |
| Aniline Compounds |
| D000588 | Amines |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |