Relief Efficacy of Lidocaine Versus Morphine for Acute Renal Colic in the Emergency Department

NCT07536594 | Not Yet Recruiting

• 1 other identifier: 5260095
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

The opioid epidemic continues to be a major public health crisis in the United States. According to the Center for Disease Control, approximately 8 million Americans reported misusing prescription opioids in 2023, with over 5 million Americans reporting that they suffer from opioid use disorder. The United States government estimates that 105,000 people died from drug overdose in 2023, and approximately 80,000 of those deaths can be attributed to opioids (\~76%). In acknowledgement of the opioid crisis, we wish to contribute to ongoing efforts to reduce unnecessary and excessive opioid prescription. In 2012, researchers in Iran published a randomized controlled trial comparing intravenous (IV) lidocaine to IV morphine for acute renal colic, reporting that 90% patients responded "successfully" in the lidocaine group versus 70% in the morphine group. They also concluded that there was a statistically significant difference between pain scores between the two groups at all time points, favoring the lidocaine group. However, the study was conducted at a single emergency department in Tabriz, Iran, with a relatively homogenous patient population, and the researchers did not explicitly define their primary outcome variable for what constituted a "successful" response in the treatment groups. The investigators of this study aim to build upon this preliminary evidence by recruiting a more diverse population to improve generalizability and by predefining pain-reduction thresholds to allow for more meaningful comparison between the interventions.

Conditions

Renal Colic; Kidney Stones, Urolithiasis, Hypocitraturia; Opioid Use During Medical Care

Keywords

renal colic; kidney stones; lidocaine; opioid use

Outcome Measures

Primary Outcomes (1)

• Response to treatment

  Pain assessment using a numeric rating scale (0 to 10) at 30 minutes

  30 minutes after completion of medication administration

Secondary Outcomes (4)

• Response to treatment

  15, 60, 90 minutes after completion of medication administration

• Adverse events

  From time of drug administration to time of patient disposition (admit, observation status, or discharge) in the emergency department, assessed up to 24 hours

• Emergency Department Length of Stay

  From time of patient registration in the emergency department to time of patient disposition (admit, observation status, or discharge) in the emergency department, assessed up to 24 hours

• Rescue medications

  From time of drug administration to time of patient disposition (admit, observation status, or discharge) in the emergency department, assessed up to 24 hours

Study Arms (2)

Lidocaine Drip

ACTIVE COMPARATOR

Weight-based dose of IV lidocaine will be 1.5 mg/kg, maximum 200 mg, delivered as IV infusion over 10 minutes

Drug: Lidocaine

Morphine, IV Push

ACTIVE COMPARATOR

Weight-based IV morphine will be 0.1 mg/kg, maximum 10 mg, delivered as IV push.

Drug: Morphine 0,1 mg/kg

Interventions

Morphine 0,1 mg/kg DRUG

We hypothesize that IV lidocaine outperforms IV morphine at 30 minutes in achieving ≥ 50% reduction in pain score for renal colic that is refractory to initial treatment with parenteral ketorolac.

Morphine, IV Push

Lidocaine DRUG

We hypothesize that IV lidocaine outperforms IV morphine at 30 minutes in achieving ≥ 50% reduction in pain score for renal colic that is refractory to initial treatment with parenteral ketorolac.

Lidocaine Drip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at time of visit
• Able and willing to consent for participation in study
• Documentation of suspected renal colic as primary complaint as evidenced by reported flank pain, back pain, abdominal pain, or groin pain, or as determined by the treating clinician
• Requires additional treatment due to inadequate analgesia or clinical suspicion of unsafe discharge secondary to pain after initial treatment with parenteral ketorolac

You may not qualify if:

• Any individual who meets any of the following criteria will be excluded from participation in this study:
• Age \< 18 years
• Use of analgesia for renal colic within 6 hours prior to clinician evaluation
• Inability or unwillingness to consent for participation in study
• Experienced a severe adverse event that required clinician intervention after initial treatment with parenteral ketorolac
• Documented history of allergic or anaphylactic reaction to NSAIDs, lidocaine, or morphine
• Documented history of cardiac arrhythmias
• Documented history of chronic use of opioid medications for unrelated diagnoses
• Currently pregnant
• Documented history of end-stage renal or hepatic dysfunction
• Clinical contraindications to NSAIDs, lidocaine, or morphine per clinician discretion

Sponsors & Collaborators

• Loma Linda University: lead

Related Publications (8)

• Garnett MF, Minino AM. Drug Overdose Deaths in the United States, 2003-2023. NCHS Data Brief. 2024 Dec;(522):1. doi: 10.15620/cdc/170565.

  PMID: 40623710 RESULT

• Krieger A, Zaidan N, Zhao P, Borin JF, Goldfarb DS. Questionable role of opioids for analgesia in renal colic and its urological interventions. BJUI Compass. 2025 Jun 11;6(6):e70038. doi: 10.1002/bco2.70038. eCollection 2025 Jun.

  PMID: 40503371 RESULT

• Seyhan AU, Yilmaz E. Treatment of Renal Colic by Nerve Blockade with Lidocaine Versus Intravenous Dexketoprofen. J Coll Physicians Surg Pak. 2021 Aug;31(8):921-925. doi: 10.29271/jcpsp.2021.08.921.

  PMID: 34320708 RESULT

• 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.

  PMID: 30770244 RESULT

• Motamed H, Maleki Verki M. Intravenous Lidocaine Compared to Fentanyl in Renal Colic Pain Management; a Randomized Clinical Trial. Emerg (Tehran). 2017;5(1):e82. doi: 10.22037/emergency.v5i1.18894. Epub 2017 Oct 23.

  PMID: 29201964 RESULT

• Firouzian A, Alipour A, Rashidian Dezfouli H, Zamani Kiasari A, Gholipour Baradari A, Emami Zeydi A, Amini Ahidashti H, Montazami M, Hosseininejad SM, Yazdani Kochuei F. Does lidocaine as an adjuvant to morphine improve pain relief in patients presenting to the ED with acute renal colic? A double-blind, randomized controlled trial. Am J Emerg Med. 2016 Mar;34(3):443-8. doi: 10.1016/j.ajem.2015.11.062. Epub 2015 Dec 1.

  PMID: 26704774 RESULT

• 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.

  PMID: 22559856 RESULT

• Eaton SH, Cashy J, Pearl JA, Stein DM, Perry K, Nadler RB. Admission rates and costs associated with emergency presentation of urolithiasis: analysis of the Nationwide Emergency Department Sample 2006-2009. J Endourol. 2013 Dec;27(12):1535-8. doi: 10.1089/end.2013.0205. Epub 2013 Nov 19.

  PMID: 24251430 RESULT

Related Links

• Centers for Disease Control and Prevention. About Prescription Opioids. Overdose Prevention. Published May 8, 2024.
• Substance Abuse and Mental Health Services Administration (SAMHSA). Key Substance Use and Mental Health Indicators in the United States: Results from the 2023 National Survey on Drug Use and Health. Published July 2024.
• Centers for Disease Control and Prevention. Understanding the opioid overdose epidemic. Overdose Prevention. Published June 9, 2025.
• Beecham GB, Goyal A. Lidocaine. National Library of Medicine. Published 2019.
• Murphy PB, Patel P, Barrett MJ. Morphine. National Library of Medicine. Published March 27, 2025.

MeSH Terms

Conditions

Renal Colic; Kidney Calculi; Urolithiasis

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Sarah Aly, DO, MSc

CONTACT

(909)558-7407; sarahaly@llu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 17, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share