Intravenous Lidocaine and Ketorolac for Pain Management
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      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: 
      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.
    

Intervention name(s): Lidocaine; Ketorolac Tromethamine; Normal Saline Drip; Normal Saline Push
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1.5 mg/kg IV lidocaine drip (given over 10 minutes); IV ketorolac 30mg push; Normal Saline Drip Placebo given over 10 minutes; Normal Saline Push Placebo
Other intervention name(s): Xylocaine; Toradol; Normal Saline; Normal Saline
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Lidocaine; Ketorolac