Abdominal PainPhase 4HIDO-LIDONCT04398316
High Dose IV Lidocaine vs Hydromorphone for Abdominal Pain in the Emergency Department
A Phase 4 study testing Lidocaine Iv and HYDROmorphone Injection in people with Abdominal Pain and Renal Colic, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial summary
Intravenous lidocaine will be given at a dose of 2 mg/kg intravenously to patients in the emergency department with a diagnosis of acute abdominal pain. Its efficacy will be compared to 1 mg of intravenous hydromorphone, with a primary endpoint of mean improvement of pain at 90 minutes. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Abdominal Pain, Renal Colic
- What is being tested?
- Lidocaine Iv and HYDROmorphone Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to 30 Jun 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must be a patient in the emergency department (ED)
- Must have acute abdominal pain, defined as abdominal or flank pain of a duration of 7 days or less
- Predicted treatment must include the use of an intravenous opiate
Who cannot join
- Cardiac conduction system impairment (QTc duration > 0.5s, QRS duration > 0.12s, PR interval <0.12s or > 0.2s)
- Known renal (CKD >2) or liver disease (Childs-Pugh B or greater)
- Hemodynamically instability, defined by the attending physician
- Pregnant or breastfeeding
- Have a known allergy to either medication
- Used of prescription or illicit opioids within the previous week
- Patients with a chronic pain disorder, defined as use of any analgesic medication on more days than not during the four weeks preceding the acute episode of pain
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: High Dose Intravenous Lidocaine vs Hydromorphone for Acute Abdominal Pain in the Emergency Department: A Randomized, Comparative Efficacy Trial
Intravenous lidocaine will be given at a dose of 2 mg/kg intravenously to patients in the emergency department with a diagnosis of acute abdominal pain. Its efficacy will be compared to 1 mg of intravenous hydromorphone, with a primary endpoint of mean improvement of pain at 90 minutes.
Read the detailed description
Abdominal pain is a common chief complaint for patients presenting to the emergency department (ED) in the United States. Intravenous opioids are commonly used to treat acute abdominal pain in the ED. These medications are highly efficacious and, when used in a monitored setting such as the ED, extremely safe. Use of opioids has fallen out of favor because of a spike in opioid-related overdose deaths throughout the United States. While use of opioids in the ED is unlikely to contribute to outpatient opioid deaths, minimizing the use of opioids in the ED will contribute to an opioid free culture, in which opioids are used only when absolutely necessary. A variety of different types of medications can be used in lieu of opioids. One such medication, intravenous lidocaine, has been used extensively for neuropathic pain, in the peri- and post-operative surgical setting, the cardiac care unit, and most recently in the emergency department.
Intravenous lidocaine has long been used to treat pain. In publications dating back to 1980, intravenous lidocaine has been shown to be an effective treatment for neuropathic pain. In the postoperative setting, intravenous lidocaine decreased pain and decreased the need for opiates. More recently, emergency medicine investigators in Iran demonstrated that intravenous lidocaine decreased pain associated with renal colic and limb ischemia. An ED-based study in the United States showed comparable efficacy between morphine and intravenous lidocaine when used for acute pain. Most recently, a prospective RCT showed 120 mg of intravenous lidocaine was efficacious for abdominal pain, albeit not as effective as 1 mg of hydromorphone. However, a subgroup analysis showed that when lidocaine was dosed at 2 mg/kg, it was equally as effective as hydromorphone.
Over the years, intravenous lidocaine has been used for a variety of indications including arrhythmia prophylaxis in patients with acute coronary syndromes. Known side effects of intravenous lidocaine range from transient neurological symptoms (dizziness, paresthesias), to cardiac dysrhythmias and seizure. To date, no deaths have been attributed to its use for treating pain, and the only documented significant complication was due to an unintentional overdose when a patient received ten times the normal dose. All reported side effects in pain patients have been transient and resolved by either stopping the drug, decreasing the infusion rate or by observation alone. Additionally, doses of 2 mg/kg have been tolerated well in the outpatient setting, operating room and ED without any serious side effects. Thus, intravenous lidocaine is an emerging medication for safe and rapid relief of pain, has no known addictive properties, and creates a potential for a pain practice paradigm shift in the United States.
We therefore propose a randomized, double blind, comparative efficacy trial to address the following aim:
To determine if a 2 mg/kg dose of intravenous lidocaine is as equally efficacious as a single dose of 1 mg intravenous hydromorphone for acute abdominal pain in the emergency department.
- Conditions
- Abdominal Pain, Renal Colic
- Being tested
- Lidocaine Iv, HYDROmorphone Injection
- Keywords
- lidocaine, hydromorphone, abdominal pain
- Medical subject headings
- Abdominal Pain, Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine IvDrug
Also called Xylocaine
2 mg/kg over 5 minutes
HYDROmorphone InjectionDrug
Also called Dilaudid
1 mg over 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Lidocaine | Experimental | Administered at a dose of 2 mg/kg over 5 minutes Receives: Drug: Lidocaine Iv |
| Intravenous Hydromorphone | Active comparator | Administered at a dose of 1 mg over 5 minutes Receives: Drug: HYDROmorphone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Improvement in Pain at 90 Minutes
The difference between the pain score at time 0 and 90 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Measured: 90 minutes
Secondary outcomes (14)
Sufficient Pain Relief
Does the patient require off-protocol medication for additional pain relief? Off-protocol defined as any opiate or NSAID
Measured: From administration of study drug until patient leaves the emergency department, up until 3 hours from administration of study drug.
Improvement in Numerical Pain Score at 15 Minutes
The difference between the pain score at time 0 and 15 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Measured: 15 minutes
Improvement in Numerical Pain Score at 30 Minutes
The difference between the pain score at time 0 and 30 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Measured: 30 minutes
Improvement in Numerical Pain Score at 60 Minutes
The difference between the pain score at time 0 and 60 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Measured: 60 minutes
Improvement in Numerical Pain Score at 120 Minutes
The difference between the pain score at time 0 and 120 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Measured: 120 minutes
Improvement in Numerical Pain Score at 150 Minutes
The difference between the pain score at time 0 and 150 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Measured: 150 minutes
Improvement in Numerical Pain Score at 180 Minutes
The difference between the pain score at time 0 and 180 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
Measured: 180 minutes
Patient Preference for the Medication They Received
If the patient were to come to the ED again for the same complaint, would they want the same study drug they received?
Measured: Day 7
Side Effects
Yes or no, did the patient have any side effects, defined as any new symptom after the administration of the study drug.
Measured: 15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes and at 7 days
Medication for Side Effects
Are any medications required to control medication side effects, defined as any new symptom after the administration of the study drug?
Measured: 15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and 180 minutes
Administration of Naloxone
Yes or no, was naloxone required after the patient received the study drug?
Measured: 15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and at 180 minutes
Change in Disposition
Yes or no, did the patients disposition change as a consequence of administration of the study drug? Example would be an adverse outcome resulting in hospitalization or other escalation of care.
Measured: 15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and at 180 minutes
Missed Diagnosis
Yes or no, did the patient have a new diagnosis within the next week?
Measured: 7 days after administration of study drug
Serious Adverse Event
Yes or no, did the patient suffer a serious adverse event? Defined as death, requiring or prolonging inpatient hospitalization, resulting in persistent or significant disability/incapacity, or is considered a significant medical event by the investigator based off of medical judgement.
Measured: 180 minutes after administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start18 Feb 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: Administrative
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elliott Chinn, DO, Principal investigator, Hennepin County Medical Center, Minneapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398316
- Sponsor's protocol ID
- 20202020
- Acronym
- HIDO-LIDO
- Status last verified
- Dec 2023
- First submitted
- 7 May 2020
- Last updated
- 17 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tremont-Lukats IW, Challapalli V, McNicol ED, Lau J, Carr DB. Systemic administration of local anesthetics to relieve neuropathic pain: a systematic review and meta-analysis. Anesth Analg. 2005 Dec;101(6):1738-1749. doi: 10.1213/01.ANE.0000186348.86792.38.
PubMed 16301253Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2.
PubMed 26184397Ventham NT, Kennedy ED, Brady RR, Paterson HM, Speake D, Foo I, Fearon KC. Efficacy of Intravenous Lidocaine for Postoperative Analgesia Following Laparoscopic Surgery: A Meta-Analysis. World J Surg. 2015 Sep;39(9):2220-34. doi: 10.1007/s00268-015-3105-6.
PubMed 26044546Sun Y, Li T, Wang N, Yun Y, Gan TJ. Perioperative systemic lidocaine for postoperative analgesia and recovery after abdominal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2012 Nov;55(11):1183-94. doi: 10.1097/DCR.0b013e318259bcd8.
PubMed 23044681Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.
PubMed 21061107Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375.
PubMed 18844267Fitzpatrick BM, Mullins ME. Intravenous lidocaine for the treatment of acute pain in the emergency department. Clin Exp Emerg Med. 2016 Jun 30;3(2):105-108. doi: 10.15441/ceem.15.103. eCollection 2016 Jun.
PubMed 27752626Soleimanpour 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.
PubMed 21714904Soleimanpour 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 22559856Firouzian 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 26704774Vahidi E, Shakoor D, Aghaie Meybodi M, Saeedi M. Comparison of intravenous lidocaine versus morphine in alleviating pain in patients with critical limb ischaemia. Emerg Med J. 2015 Jul;32(7):516-9. doi: 10.1136/emermed-2014-203944. Epub 2014 Aug 21.
PubMed 25147364Clattenburg EJ, Nguyen A, Yoo T, Flores S, Hailozian C, Louie D, Herring AA. Intravenous Lidocaine Provides Similar Analgesia to Intravenous Morphine for Undifferentiated Severe Pain in the Emergency Department: A Pilot, Unblinded Randomized Controlled Trial. Pain Med. 2019 Apr 1;20(4):834-839. doi: 10.1093/pm/pny031.
PubMed 29741660Chinn E, Friedman BW, Naeem F, Irizarry E, Afrifa F, Zias E, Jones MP, Pearlman S, Chertoff A, Wollowitz A, Gallagher EJ. Randomized Trial of Intravenous Lidocaine Versus Hydromorphone for Acute Abdominal Pain in the Emergency Department. Ann Emerg Med. 2019 Aug;74(2):233-240. doi: 10.1016/j.annemergmed.2019.01.021. Epub 2019 Feb 26.
PubMed 30819520
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Intravenous Lidocaine vs Hydromorphone for Acute Abdominal Pain in the Emergency Department: A Randomized, Comparative Efficacy Trial
- ClinicalTrials.gov ID
- NCT04398316
- Acronym / sponsor ID
- HIDO-LIDO / 20202020
- Conditions
- Abdominal Pain, Renal Colic
- Keywords
- lidocaine, hydromorphone, abdominal pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Posted 17 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intravenous lidocaine will be given at a dose of 2 mg/kg intravenously to patients in the emergency department with a diagnosis of acute abdominal pain. Its efficacy will be compared to 1 mg of intravenous hydromorphone, with a primary endpoint of mean improvement of pain at 90 minutes.
Detailed description
Abdominal pain is a common chief complaint for patients presenting to the emergency department (ED) in the United States. Intravenous opioids are commonly used to treat acute abdominal pain in the ED. These medications are highly efficacious and, when used in a monitored setting such as the ED, extremely safe. Use of opioids has fallen out of favor because of a spike in opioid-related overdose deaths throughout the United States. While use of opioids in the ED is unlikely to contribute to outpatient opioid deaths, minimizing the use of opioids in the ED will contribute to an opioid free culture, in which opioids are used only when absolutely necessary. A variety of different types of medications can be used in lieu of opioids. One such medication, intravenous lidocaine, has been used extensively for neuropathic pain, in the peri- and post-operative surgical setting, the cardiac care unit, and most recently in the emergency department.
Intravenous lidocaine has long been used to treat pain. In publications dating back to 1980, intravenous lidocaine has been shown to be an effective treatment for neuropathic pain. In the postoperative setting, intravenous lidocaine decreased pain and decreased the need for opiates. More recently, emergency medicine investigators in Iran demonstrated that intravenous lidocaine decreased pain associated with renal colic and limb ischemia. An ED-based study in the United States showed comparable efficacy between morphine and intravenous lidocaine when used for acute pain. Most recently, a prospective RCT showed 120 mg of intravenous lidocaine was efficacious for abdominal pain, albeit not as effective as 1 mg of hydromorphone. However, a subgroup analysis showed that when lidocaine was dosed at 2 mg/kg, it was equally as effective as hydromorphone.
Over the years, intravenous lidocaine has been used for a variety of indications including arrhythmia prophylaxis in patients with acute coronary syndromes. Known side effects of intravenous lidocaine range from transient neurological symptoms (dizziness, paresthesias), to cardiac dysrhythmias and seizure. To date, no deaths have been attributed to its use for treating pain, and the only documented significant complication was due to an unintentional overdose when a patient received ten times the normal dose. All reported side effects in pain patients have been transient and resolved by either stopping the drug, decreasing the infusion rate or by observation alone. Additionally, doses of 2 mg/kg have been tolerated well in the outpatient setting, operating room and ED without any serious side effects. Thus, intravenous lidocaine is an emerging medication for safe and rapid relief of pain, has no known addictive properties, and creates a potential for a pain practice paradigm shift in the United States.
We therefore propose a randomized, double blind, comparative efficacy trial to address the following aim:
To determine if a 2 mg/kg dose of intravenous lidocaine is as equally efficacious as a single dose of 1 mg intravenous hydromorphone for acute abdominal pain in the emergency department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Lidocaine | Experimental | Drug: Lidocaine IvAdministered at a dose of 2 mg/kg over 5 minutes |
| Intravenous Hydromorphone | Active comparator | Drug: HYDROmorphone InjectionAdministered at a dose of 1 mg over 5 minutes |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must be a patient in the emergency department (ED)
- Must have acute abdominal pain, defined as abdominal or flank pain of a duration of 7 days or less
- Predicted treatment must include the use of an intravenous opiate
Key exclusion criteria (7 listed)
- Cardiac conduction system impairment (QTc duration > 0.5s, QRS duration > 0.12s, PR interval <0.12s or > 0.2s)
- Known renal (CKD >2) or liver disease (Childs-Pugh B or greater)
- Hemodynamically instability, defined by the attending physician
- Pregnant or breastfeeding
- Have a known allergy to either medication
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 |
|---|---|---|
| Lidocaine IvAlso: Xylocaine2 mg/kg over 5 minutes | Drug | Intravenous Lidocaine |
| HYDROmorphone InjectionAlso: Dilaudid1 mg over 5 minutes | Drug | Intravenous Hydromorphone |
Primary outcome
Mean Improvement in Pain at 90 Minutes
Time frame: 90 minutes
The difference between the pain score at time 0 and 90 minutes. Pain score ranges from 0 (no pain) to 10 (maximum pain).
14 secondary outcomes
Sufficient Pain Relief
Time frame: From administration of study drug until patient leaves the emergency department, up until 3 hours from administration of study drug.
Improvement in Numerical Pain Score at 15 Minutes
Time frame: 15 minutes
Improvement in Numerical Pain Score at 30 Minutes
Time frame: 30 minutes
Improvement in Numerical Pain Score at 60 Minutes
Time frame: 60 minutes
Improvement in Numerical Pain Score at 120 Minutes
Time frame: 120 minutes
Improvement in Numerical Pain Score at 150 Minutes
Time frame: 150 minutes
Improvement in Numerical Pain Score at 180 Minutes
Time frame: 180 minutes
Patient Preference for the Medication They Received
Time frame: Day 7
Side Effects
Time frame: 15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes and at 7 days
Medication for Side Effects
Time frame: 15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and 180 minutes
Administration of Naloxone
Time frame: 15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and at 180 minutes
Change in Disposition
Time frame: 15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and at 180 minutes
Missed Diagnosis
Time frame: 7 days after administration of study drug
Serious Adverse Event
Time frame: 180 minutes after administration of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16301253Tremont-Lukats IW, Challapalli V, McNicol ED, Lau J, Carr DB. Systemic administration of local anesthetics to relieve neuropathic pain: a systematic review and meta-analysis. Anesth Analg. 2005 Dec;101(6):1738-1749. doi: 10.1213/01.ANE.0000186348.86792.38.
- Background: PubMed 26184397Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2.
- Background: PubMed 26044546Ventham NT, Kennedy ED, Brady RR, Paterson HM, Speake D, Foo I, Fearon KC. Efficacy of Intravenous Lidocaine for Postoperative Analgesia Following Laparoscopic Surgery: A Meta-Analysis. World J Surg. 2015 Sep;39(9):2220-34. doi: 10.1007/s00268-015-3105-6.
- Background: PubMed 23044681Sun Y, Li T, Wang N, Yun Y, Gan TJ. Perioperative systemic lidocaine for postoperative analgesia and recovery after abdominal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2012 Nov;55(11):1183-94. doi: 10.1097/DCR.0b013e318259bcd8.
- Background: PubMed 21061107Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.
- Background: PubMed 18844267Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375.
- Background: PubMed 27752626Fitzpatrick BM, Mullins ME. Intravenous lidocaine for the treatment of acute pain in the emergency department. Clin Exp Emerg Med. 2016 Jun 30;3(2):105-108. doi: 10.15441/ceem.15.103. eCollection 2016 Jun.
- Background: PubMed 21714904Soleimanpour 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.
- Background: 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.
- Background: 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.
- Background: PubMed 25147364Vahidi E, Shakoor D, Aghaie Meybodi M, Saeedi M. Comparison of intravenous lidocaine versus morphine in alleviating pain in patients with critical limb ischaemia. Emerg Med J. 2015 Jul;32(7):516-9. doi: 10.1136/emermed-2014-203944. Epub 2014 Aug 21.
- Background: PubMed 29741660Clattenburg EJ, Nguyen A, Yoo T, Flores S, Hailozian C, Louie D, Herring AA. Intravenous Lidocaine Provides Similar Analgesia to Intravenous Morphine for Undifferentiated Severe Pain in the Emergency Department: A Pilot, Unblinded Randomized Controlled Trial. Pain Med. 2019 Apr 1;20(4):834-839. doi: 10.1093/pm/pny031.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Elliott Chinn, DO principal investigator
Hennepin County Medical Center, Minneapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine Iv and HYDROmorphone Injection in people with Abdominal Pain and Renal Colic, run by Hennepin Healthcare Research Institute at 1 site in United States.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Improvement in Pain at 90 Minutes (time frame: 90 minutes). 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 NCT04398316, which also lists 13 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 Jan 2024.