Intravenous Lidocaine and Ketorolac for Pain Management
A Randomized Trial Comparing the Combination of Intravenous Lidocaine and Ketorolac to Either Analgesics Alone for ED Patients With Acute Renal Colic
1 other identifier
interventional
150
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 pain
Started Oct 2016
Longer than P75 for phase_4 pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2016
CompletedFirst Posted
Study publicly available on registry
September 16, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2019
CompletedResults Posted
Study results publicly available
March 18, 2020
CompletedMarch 18, 2020
March 1, 2020
2 years
September 5, 2016
February 26, 2020
March 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Lidocaine and normal saline push
ACTIVE COMPARATOR1.5mg/kg IV Lidocaine Drip (given over 10 minutes) and normal saline push
Ketorolac and normal saline drip
ACTIVE COMPARATORIV Ketorolac Tromethamine 30mg push and 10 minute normal saline drip
Lidocaine and Ketorolac
ACTIVE COMPARATORIV Lidocaine Drip and IV Ketorolac Push
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (12)
Golzari SE, Soleimanpour H, Rahmani F, Zamani Mehr N, Safari S, Heshmat Y, Ebrahimi Bakhtavar H. Therapeutic approaches for renal colic in the emergency department: a review article. Anesth Pain Med. 2014 Feb 13;4(1):e16222. doi: 10.5812/aapm.16222. eCollection 2014 Feb.
PMID: 24701420BACKGROUNDTalati, J, Tiselius, H.-G, Albala, D.M, YE, Z. Urolithiasis: Basic Science and Clinical Practice. Springer Science & Business Media, Dec 22, 2012
BACKGROUNDSandhu DP, Iacovou JW, Fletcher MS, Kaisary AV, Philip NH, Arkell DG. A comparison of intramuscular ketorolac and pethidine in the alleviation of renal colic. Br J Urol. 1994 Dec;74(6):690-3. doi: 10.1111/j.1464-410x.1994.tb07107.x.
PMID: 7827834BACKGROUNDLarkin GL, Peacock WF 4th, Pearl SM, Blair GA, D'Amico F. Efficacy of ketorolac tromethamine versus meperidine in the ED treatment of acute renal colic. Am J Emerg Med. 1999 Jan;17(1):6-10. doi: 10.1016/s0735-6757(99)90003-7.
PMID: 9928687BACKGROUNDO'Connor A, Schug SA, Cardwell H. A comparison of the efficacy and safety of morphine and pethidine as analgesia for suspected renal colic in the emergency setting. J Accid Emerg Med. 2000 Jul;17(4):261-4. doi: 10.1136/emj.17.4.261.
PMID: 10921813BACKGROUNDSafdar B, Degutis LC, Landry K, Vedere SR, Moscovitz HC, D'Onofrio G. Intravenous morphine plus ketorolac is superior to either drug alone for treatment of acute renal colic. Ann Emerg Med. 2006 Aug;48(2):173-81, 181.e1. doi: 10.1016/j.annemergmed.2006.03.013.
PMID: 16953530BACKGROUNDCatapano MS. The analgesic efficacy of ketorolac for acute pain. J Emerg Med. 1996 Jan-Feb;14(1):67-75. doi: 10.1016/0736-4679(95)02052-7.
PMID: 8655940BACKGROUNDCastellsague J, Riera-Guardia N, Calingaert B, Varas-Lorenzo C, Fourrier-Reglat A, Nicotra F, Sturkenboom M, Perez-Gutthann S; Safety of Non-Steroidal Anti-Inflammatory Drugs (SOS) Project. Individual NSAIDs and upper gastrointestinal complications: a systematic review and meta-analysis of observational studies (the SOS project). Drug Saf. 2012 Dec 1;35(12):1127-46. doi: 10.2165/11633470-000000000-00000.
PMID: 23137151BACKGROUNDDuthie DJ, Nimmo WS. Adverse effects of opioid analgesic drugs. Br J Anaesth. 1987 Jan;59(1):61-77. doi: 10.1093/bja/59.1.61.
PMID: 2881564BACKGROUNDSoleimanpour H, Hassanzadeh K, Mohammadi DA, Vaezi H, Esfanjani RM. Parenteral lidocaine for treatment of intractable renal colic: a case series. J Med Case Rep. 2011 Jun 29;5:256. doi: 10.1186/1752-1947-5-256.
PMID: 21714904BACKGROUNDSoleimanpour H, Hassanzadeh K, Vaezi H, Golzari SE, Esfanjani RM, Soleimanpour M. Effectiveness of intravenous lidocaine versus intravenous morphine for patients with renal colic in the emergency department. BMC Urol. 2012 May 4;12:13. doi: 10.1186/1471-2490-12-13.
PMID: 22559856BACKGROUNDMotov S, Fassassi C, Drapkin J, Butt M, Hossain R, Likourezos A, Monfort R, Brady J, Rothberger N, Mann SS, Flom P, Gulati V, Marshall J. Comparison of intravenous lidocaine/ketorolac combination to either analgesic alone for suspected renal colic pain in the ED. Am J Emerg Med. 2020 Feb;38(2):165-172. doi: 10.1016/j.ajem.2019.01.048. Epub 2019 Jan 30.
PMID: 30770244DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Antonios Likourezos
- Organization
- Maimonides Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Sergey Motov, MD
Maimonides Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Manager
Study Record Dates
First Submitted
September 5, 2016
First Posted
September 16, 2016
Study Start
October 1, 2016
Primary Completion
October 4, 2018
Study Completion
September 10, 2019
Last Updated
March 18, 2020
Results First Posted
March 18, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share