Relief Efficacy of Lidocaine Versus Morphine for Acute Renal Colic in the Emergency Department
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLoma Linda University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lidocaine
DrugWe 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 0,1 mg/kg
DrugWe 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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Lidocaine DripActive comparator 1 intervention
Group B: Morphine, IV PushActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Response to treatment
Pain assessment using a numeric rating scale (0 to 10) at 30 minutes
Time frame
30 minutes after completion of medication administrationSecondary outcomes
1
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 administration2
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 hours3
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 hours4
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 hoursLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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