High Dose IV Lidocaine vs Hydromorphone for Abdominal Pain in the Emergency Department

Abdominal Pain Clinical Trial

— HIDO-LIDO  

Official title:

High Dose Intravenous Lidocaine vs Hydromorphone for Acute Abdominal Pain in the Emergency Department: A Randomized, Comparative Efficacy Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04398316
• Other study ID #: 20202020
• Status: Terminated
• Phase: Phase 4
• Start date: February 18, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2023
• Source: Hennepin Healthcare Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Abdominal Pain
• Emergencies
• Renal Colic

Intervention

Drug:
• Lidocaine Iv
2 mg/kg over 5 minutes
• HYDROmorphone Injection
1 mg over 5 minutes

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Hennepin Healthcare Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (13)

Chinn 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. — View Citation

Clattenburg 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. — View Citation

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. — View Citation

Fitzpatrick 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. — View Citation

Kranke 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. — View Citation

Marret 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. — View Citation

Soleimanpour 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. — View Citation

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. — View Citation

Sun 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. Erratum In: Dis Colon Rectum. 2013 Feb;52(2):271. — View Citation

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. — View Citation

Vahidi 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. — View Citation

Ventham 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. — View Citation

Vigneault 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	90 minutes
Secondary	Sufficient Pain Relief	Does the patient require off-protocol medication for additional pain relief? Off-protocol defined as any opiate or NSAID	From administration of study drug until patient leaves the emergency department, up until 3 hours from administration of study drug.
Secondary	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).	15 minutes
Secondary	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).	30 minutes
Secondary	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).	60 minutes
Secondary	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).	120 minutes
Secondary	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).	150 minutes
Secondary	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).	180 minutes
Secondary	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?	Day 7
Secondary	Side Effects	Yes or no, did the patient have any side effects, defined as any new symptom after the administration of the study drug.	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
Secondary	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?	15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and 180 minutes
Secondary	Administration of Naloxone	Yes or no, was naloxone required after the patient received the study drug?	15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and at 180 minutes
Secondary	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.	15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and at 180 minutes
Secondary	Missed Diagnosis	Yes or no, did the patient have a new diagnosis within the next week?	7 days after administration of study drug
Secondary	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.	180 minutes after administration of study drug

External Links

•   Emergency Department Visits for Chest Pain and Abdominal Pain: United States, 1999-2008