Renal ColicRELIEF-RCNCT07536594
Relief Efficacy of Lidocaine Versus Morphine for Acute Renal Colic in the Emergency Department
A study testing Lidocaine and Morphine 0,1 mg/kg in people with Renal Colic and Kidney Stones, Urolithiasis, Hypocitraturia, run by Loma Linda University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Colic, Kidney Stones, Urolithiasis, Hypocitraturia, Opioid Use During Medical Care
- What is being tested?
- Lidocaine and Morphine 0,1 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible for inclusion in the study, an individual must meet all of the following criteria:
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: RELIEF-RC: Relief Efficacy of LIdocaine Versus morphinE For Acute Renal Colic in the Emergency Department
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.
Read the detailed description
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
- To compare reduction in pain scores at 15, 60, and 90 minutes between the two intervention groups;
- To determine if there is a statistically significant difference in emergency department length of stay (ED LOS) between the two intervention groups
- To determine if there is a statistically significant difference in need for further rescue medications between the two intervention groups
- To determine the incidence of adverse effects between the two intervention groups
- To evaluate whether there is a correlation between age and efficacy of treatment between the two intervention groups
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
- Loma Linda University Medical Center - Adult Emergency Department (Adult ED)
- Loma Linda University Medical Center - East Campus Advanced Urgent Care (AUC)
Primary Outcome Variables
● Response to treatment: pain assessment using a numeric rating scale (0 to 10) at 30 minutes
Secondary and Exploratory Outcome Variables
- Response to treatment: pain assessment using a numeric rating scale (0 to 10) at 15, 60, and 90 minutes
- Adverse events attributed to IV lidocaine or IV morphine
- ED LOS
- Need for additional rescue medications after either IV lidocaine or IV morphine
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.
- Being tested
- Lidocaine, Morphine 0,1 mg/kg
- Keywords
- renal colic, kidney stones, lidocaine, opioid use
- Medical subject headings
- Renal Colic, Kidney Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
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 0,1 mg/kgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Lidocaine |
| Morphine, IV Push | Active comparator | Weight-based IV morphine will be 0.1 mg/kg, maximum 10 mg, delivered as IV push. Receives: Drug: Morphine 0,1 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
Pain assessment using a numeric rating scale (0 to 10) at 30 minutes
Measured: 30 minutes after completion of medication administration
Secondary outcomes (4)
Response to treatment
Pain assessment using a numeric rating scale (0 to 10) at 15, 60, and 90 minutes
Measured: 15, 60, 90 minutes after completion of medication administration
Adverse events
Adverse events attributed to IV lidocaine or IV morphine
Measured: 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
Measured: 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
Measured: From time of drug administration to time of patient disposition (admit, observation status, or discharge) in the emergency department, assessed up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Aly, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536594
- Sponsor's protocol ID
- 5260095
- Acronym
- RELIEF-RC
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For patient data protection; all recruitment is taking place at once facility. Deidentified patient data will be made available upon request.
Publications
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.
PubMed 40623710Krieger 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.
PubMed 40503371Seyhan 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.
PubMed 34320708Motov 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.
PubMed 30770244Motamed 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.
PubMed 29201964Firouzian 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.
PubMed 26704774Soleimanpour 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.
PubMed 22559856Eaton 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.
PubMed 24251430
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELIEF-RC: Relief Efficacy of LIdocaine Versus morphinE For Acute Renal Colic in the Emergency Department
- ClinicalTrials.gov ID
- NCT07536594
- Acronym / sponsor ID
- RELIEF-RC / 5260095
- Keywords
- renal colic, kidney stones, lidocaine, opioid use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- To compare reduction in pain scores at 15, 60, and 90 minutes between the two intervention groups;
- To determine if there is a statistically significant difference in emergency department length of stay (ED LOS) between the two intervention groups
- To determine if there is a statistically significant difference in need for further rescue medications between the two intervention groups
- To determine the incidence of adverse effects between the two intervention groups
- To evaluate whether there is a correlation between age and efficacy of treatment between the two intervention groups
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
- Loma Linda University Medical Center - Adult Emergency Department (Adult ED)
- Loma Linda University Medical Center - East Campus Advanced Urgent Care (AUC)
Primary Outcome Variables
● Response to treatment: pain assessment using a numeric rating scale (0 to 10) at 30 minutes
Secondary and Exploratory Outcome Variables
- Response to treatment: pain assessment using a numeric rating scale (0 to 10) at 15, 60, and 90 minutes
- Adverse events attributed to IV lidocaine or IV morphine
- ED LOS
- Need for additional rescue medications after either IV lidocaine or IV morphine
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Drip | Active comparator | Drug: LidocaineWeight-based dose of IV lidocaine will be 1.5 mg/kg, maximum 200 mg, delivered as IV infusion over 10 minutes |
| Morphine, IV Push | Active comparator | Drug: Morphine 0,1 mg/kgWeight-based IV morphine will be 0.1 mg/kg, maximum 10 mg, delivered as IV push. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In order to be eligible for inclusion in the study, an individual must meet all of the following criteria:
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineWe 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. | Drug | Lidocaine Drip |
| Morphine 0,1 mg/kgWe 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. | Drug | Morphine, IV Push |
Primary outcome
Response to treatment
Time frame: 30 minutes after completion of medication administration
Pain assessment using a numeric rating scale (0 to 10) at 30 minutes
4 secondary outcomes
Response to treatment
Time frame: 15, 60, 90 minutes after completion of medication administration
Adverse events
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Results publication: PubMed 40623710Garnett MF, Minino AM. Drug Overdose Deaths in the United States, 2003-2023. NCHS Data Brief. 2024 Dec;(522):1. doi: 10.15620/cdc/170565.
- Results publication: PubMed 40503371Krieger 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.
- Results publication: PubMed 34320708Seyhan 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.
- Results publication: PubMed 30770244Motov 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.
- Results publication: PubMed 29201964Motamed 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.
- Results publication: PubMed 26704774Firouzian 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.
- Results publication: PubMed 22559856Soleimanpour 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.
- Results publication: PubMed 24251430Eaton 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.
- Centers for Disease Control and Prevention. About Prescription Opioids. Overdose Prevention. Published May 8, 2024.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Centers for Disease Control and Prevention. Understanding the opioid overdose epidemic. Overdose Prevention. Published June 9, 2025.Link provided by the sponsor.
- Beecham GB, Goyal A. Lidocaine. National Library of Medicine. Published 2019.Link provided by the sponsor.
- Murphy PB, Patel P, Barrett MJ. Morphine. National Library of Medicine. Published March 27, 2025.Link provided by the sponsor.
- Individual participant dataSharing planned: No. For patient data protection; all recruitment is taking place at once facility. Deidentified patient data will be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Morphine 0,1 mg/kg in people with Renal Colic and Kidney Stones, Urolithiasis, Hypocitraturia, run by Loma Linda University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Aly, DO, MSc ((909)558-7407, sarahaly@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment (time frame: 30 minutes after completion of medication administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07536594, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.