An interventional study of Lidocaine and Morphine 0,1 mg/kg in Renal Colic, Kidney Stones, Urolithiasis, Hypocitraturia and Opioid Use During Medical Care, sponsored by Loma Linda University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment
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.
Purpose
● To determine whether IV lidocaine is more efficacious than IV morphine in decreasing or resolving acute renal colic pain refractory to initial treatment with parenteral ketorolac
Primary Objective ● To compare the efficacy of IV lidocaine versus IV morphine in achieving at least 50% reduction of pain score at 30 minutes for renal colic requiring rescue medication after initial treatment with parenteral ketorolac
Secondary Objectives
Study Design This study is a prospective randomized controlled trial. Study participants will be randomized to receive either IV lidocaine or IV morphine if they fail initial standard treatment with parenteral ketorolac for suspected acute renal colic.
Study Date Range and Duration The estimated study period will be from 1/1/2026 to 12/31/2027.
The study will be carried out for two calendar years, and may be halted early when sufficient participant enrollment has occurred.
Number of Study Sites
Primary Outcome Variables
● Response to treatment: pain assessment using a numeric rating scale (0 to 10) at 30 minutes
Secondary and Exploratory Outcome Variables
Study Population Study participants will be enrolled from patients who have suspected renal colic as determined by the treating clinician at the Loma Linda Adult ED or AUC.
Number of Participants This study seeks to enroll at least 248 patients over the study period, with at least 190 patients required to achieve a standard statistical power of 80%. Patients will be randomized into two groups - 124 patients per group.
Study Schedule All data and information, including consent and screening, will be gathered during the course of a patient's single visit at the Loma Linda Adult ED or AUC.
79 studies on the registry are indexed under Renal Colic; 10 are open to participants now.
This study's planned enrollment of 250 is above the median of 118 across 60 interventional studies indexed under Renal Colic.
Browse Renal Colic studies →Loma Linda University is the lead sponsor of 306 studies on the registry; 46 are open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 23 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible for inclusion in the study, an individual must meet all of the following criteria:
Exclusion Criteria:
Any individual who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight-based dose of IV lidocaine will be 1.5 mg/kg, maximum 200 mg, delivered as IV infusion over 10 minutes
Drug: Lidocaine
Weight-based IV morphine will be 0.1 mg/kg, maximum 10 mg, delivered as IV push.
Drug: Morphine 0,1 mg/kg
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.
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.
Response to treatment
Pain assessment using a numeric rating scale (0 to 10) at 30 minutes
Time frame: 30 minutes after completion of medication administration
Response to treatment
Pain assessment using a numeric rating scale (0 to 10) at 15, 60, and 90 minutes
Time frame: 15, 60, 90 minutes after completion of medication administration
Adverse events
Adverse events attributed to IV lidocaine or IV morphine
Time frame: 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
Time frame: 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
Need for additional rescue medications after either IV lidocaine or IV morphine
Time frame: From time of drug administration to time of patient disposition (admit, observation status, or discharge) in the emergency department, assessed up to 24 hours
No study locations are listed for this record.
Plan to share: No — For patient data protection; all recruitment is taking place at once facility. Deidentified patient data will be made available upon request.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine