Intravenous Lidocaine and Ketorolac for Pain Management

NCT ID: NCT02902770

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-09-10

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.

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lidocaine and normal saline push

1.5mg/kg IV Lidocaine Drip (given over 10 minutes) and normal saline push

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

1.5 mg/kg IV lidocaine drip (given over 10 minutes)

Normal Saline Push

Intervention Type: DRUG

Normal Saline Push Placebo

Ketorolac and normal saline drip

IV Ketorolac Tromethamine 30mg push and 10 minute normal saline drip

Group Type: ACTIVE_COMPARATOR

Ketorolac Tromethamine

Intervention Type: DRUG

IV ketorolac 30mg push

Normal Saline Drip

Intervention Type: DRUG

Normal Saline Drip Placebo given over 10 minutes

Lidocaine and Ketorolac

IV Lidocaine Drip and IV Ketorolac Push

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

1.5 mg/kg IV lidocaine drip (given over 10 minutes)

Ketorolac Tromethamine

Intervention Type: DRUG

IV ketorolac 30mg push

Interventions

Lidocaine

1.5 mg/kg IV lidocaine drip (given over 10 minutes)

Intervention Type: DRUG

Ketorolac Tromethamine

IV ketorolac 30mg push

Intervention Type: DRUG

Normal Saline Drip

Normal Saline Drip Placebo given over 10 minutes

Intervention Type: DRUG

Normal Saline Push

Normal Saline Push Placebo

Intervention Type: DRUG

Other Intervention Names

Xylocaine; Toradol; Normal Saline; Normal Saline

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antonios Likourezos

OTHER

Sponsor Role: lead

Responsible Party

Antonios Likourezos

Research Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sergey Motov, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

References

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.

Reference Type: BACKGROUND

PMID: 24701420 (View on PubMed)

Talati, J, Tiselius, H.-G, Albala, D.M, YE, Z. Urolithiasis: Basic Science and Clinical Practice. Springer Science & Business Media, Dec 22, 2012

Reference Type: BACKGROUND

Sandhu 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.

Reference Type: BACKGROUND

PMID: 7827834 (View on PubMed)

Larkin 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.

Reference Type: BACKGROUND

PMID: 9928687 (View on PubMed)

O'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.

Reference Type: BACKGROUND

PMID: 10921813 (View on PubMed)

Safdar 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.

Reference Type: BACKGROUND

PMID: 16953530 (View on PubMed)

Catapano 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.

Reference Type: BACKGROUND

PMID: 8655940 (View on PubMed)

Castellsague 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.

Reference Type: BACKGROUND

PMID: 23137151 (View on PubMed)

Duthie 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.

Reference Type: BACKGROUND

PMID: 2881564 (View on PubMed)

Soleimanpour 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.

Reference Type: BACKGROUND

PMID: 21714904 (View on PubMed)

Soleimanpour 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.

Reference Type: BACKGROUND

PMID: 22559856 (View on PubMed)

Motov 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.

Reference Type: DERIVED

PMID: 30770244 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-03-09

Identifier Type: -

Identifier Source: org_study_id