Intravenous Lidocaine and Ketorolac for Pain Management

Study Overview
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Brief Summary
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The literature regarding analgesic modalities, their combinations and routes of administrations for patients with pain related to renal colic is expanding. NSAID's (IV ketorolac) and opioids (morphine) constitutes the mainstay of treatment of renal colic either alone or in combinations. Despite their synergism and analgesic superiority when administered together, both classes of these medications possess a set of unfavorable side effects that limit their use. Emerging data of the use of IV lidocaine for patients with renal colic demonstrated good analgesic efficacy and safety profile. However, none of the trials directly compared lidocaine to ketorolac or the combination of both as viable options in patients unable to tolerate or to have serious contraindications to opioids. We designed a double-blinded, randomized, controlled trial to evaluate analgesic efficacy, safety and feasibility of non-opioid analgesics and their combinations in patients with renal colic. The hypothesis and proposed study will try to determine if a combination of IV lidocaine and reduced dose of IV ketorolac is superior to either drug alone and if this non-opioid analgesic modality is effective for controlling pain of renal colic origin.

Detailed Description
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The investigators designed a double-blind, randomized, clinical trial to evaluate analgesic efficacy, safety and feasibility of non-opioid analgesics IV Lidocaine and IV Ketorolac and combination of both in patients with renal colic. The hypothesis and proposed study will try to determine if a combination of IV lidocaine and IV ketorolac is superior to either drug alone and if this non-opioid analgesic combination is effective for controlling pain of renal colic origin. The trial will compare pain scores at 15 min and 30 min between and within the three treatment groups of the study: IV ketorolac 30mg push and 10 minute normal saline drip placebo, 1.5mg/kg IV lidocaine drip (given over 10 minutes) and normal saline push placebo, or IV ketorolac push and IV lidocaine drip. Once a patient is enrolled, the on duty ED pharmacist will prepare any one of the three treatment groups based on a predetermined randomization list generated via SPSS 19.0.The study investigators will record pain scores, vital signs, and side effects at baseline, 15, 30 and 60 minutes post-medication administration. If the patient still reports pain of five or greater and requests additional pain relief then morphine at 0.1mg/kg will be given as the rescue analgesic. Blinding of medication from the patient, research team, and staff will be strictly maintained by the pharmacist investigators. Sample Size Calculation: Fifty per group or 150 is needed given a standard 1.3 as the minimum clinically significant score and 3.0 as our standard deviation at 80% power and a=.05.

Official Title
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A Randomized Trial Comparing the Combination of Intravenous Lidocaine and Ketorolac to Either Analgesics Alone for ED Patients With Acute Renal Colic

Conditions
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Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Ketorolac Tromethamine
* Drug: Normal Saline Drip
* Drug: Normal Saline Push


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Emergency Medicine Patient clinical diagnosis of acute renal colic pain score of >=5 out of 10 on the numeric rating scale - age 18 - 64 years of age Exclusion Criteria: documented or suspected pregnancy, breastfeeding contraindication to nonsteroidal anti-inflammatory drugs or lidocaine known renal dysfunction received analgesics within 4 hours before presentation history of bleeding diathesis history of peptic ulcer disease current use of warfarin HR<50 or >150 history of cardiac arrhythmias peritonitis or presence of any peritoneal sign altered mental status weight > 100kg

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine and normal saline push<br>1.5mg/kg IV Lidocaine Drip (given over 10 minutes) and normal saline push | Drug: Lidocaine<br>* 1.5 mg/kg IV lidocaine drip (given over 10 minutes)<br>* Other names: Xylocaine;Drug: Normal Saline Push<br>* Normal Saline Push Placebo<br>* Other names: Normal Saline;|
| Active Comparator: Ketorolac and normal saline drip<br>IV Ketorolac Tromethamine 30mg push and 10 minute normal saline drip | Drug: Ketorolac Tromethamine<br>* IV ketorolac 30mg push<br>* Other names: Toradol;Drug: Normal Saline Drip<br>* Normal Saline Drip Placebo given over 10 minutes<br>* Other names: Normal Saline;|
| Active Comparator: Lidocaine and Ketorolac<br>IV Lidocaine Drip and IV Ketorolac Push | Drug: Lidocaine<br>* 1.5 mg/kg IV lidocaine drip (given over 10 minutes)<br>* Other names: Xylocaine;Drug: Ketorolac Tromethamine<br>* IV ketorolac 30mg push<br>* Other names: Toradol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score at 30 Minutes | The trial will compare the patient's pain score on a 11 point Likert scale, ranging from 0 to 10 with 0 being no pain, 5 moderate pain and 10 very severe pain, at 30 minutes | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Lidocaine, Ketorolac