Lidocaine Intravenous in the Emergency Department For Sickle Cell Crisis

NCT04614610 | Unknown Phase 2 FDA Drug

• 1 other identifier: 20-58
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

Sickle cell crisis continues to be a frequent presentation to emergency departments. Patients presenting will often require immediate treatment for their pain and often times this will include opioids. The opioid epidemic has cost thousands of lives; and continues to be a significant problem posing several challenges when treating patients presenting with sickle cell disease. Primarily, opioids remain the mainstay of treatment for these patients and the push to address the opioid crisis may present challenges for adequate opioid administration in patients suffering from a sickle cell crisis while hospitals find ways to curb the opioid crisis overall. Opioid treatment for patients in acute vaso-occlusive crisis has significantly contributed to quality of life and life expectancy of patients with this diagnosis. Measures should continue to attempt to administer a multi-model approach to sickle cell patients to minimize the morphine milligram equivalents in these patients while also successfully addressing the patient's pain. IV lidocaine is a pain medication that has been evaluated in several painful experiences, such as in renal colic. A few case reports have shown IV lidocaine use in sickle cell can be a potential effective adjunct medication to opioids to treat pain and reduce further opioid requirements. Currently, no prospective controlled trial exists to evaluate the true benefit of IV lidocaine in this population. Our study aims to evaluate IV lidocaine as an adjunct to opioid treatment in the emergency department to determine if improved pain is achieved and if there is a reduction in overall morphine milligram equivalents throughout the emergency department visit.

Conditions

Sickle Cell Disease; Sickle Cell Crisis; Pain, Acute

Keywords

lidocaine; ALTO; sickle cell pain

Outcome Measures

Primary Outcomes (1)

• Change in pain at 30 minutes

  Change of visual analog pain scale (VAS, 0-10) at 30 minutes post-infusion of lidocaine or placebo.

  from pre-lidocaine infusion to 30 minutes post-infusion

Secondary Outcomes (8)

• Total opiate dosage received

  from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)

• % Patients requiring additional opiate administration

  from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)

• Time to next opiate administered

  from administration of lidocaine infusion until patient disposition (up to 12 hours) or next opiate administered

• Total MME post-lidocaine up to 12 hours

  12 hours post-lidocaine or placebo infusion.

• Percentage of patients discharged from ED

  from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Lidocaine 1.5mg/kg (Max: 200mg) in dextrose 5% 100mL over 10 minutes along with either morphine 0.1-0.15mg/kg IV OR hydromorphone 0.01-0.02mg/kg IV.

Drug: Lidocaine Iv

Placebo

PLACEBO COMPARATOR

Dextrose 5% 100mL (placebo) over 10 minutes along with either morphine 0.1-0.15mg/kg IV OR hydromorphone 0.01-0.02mg/kg IV.

Drug: Placebo

Interventions

Lidocaine Iv DRUG

Lidocaine 1.5mg/kg (Max dose: 200mg) in Dextrose 5% 100mL over 10 minutes

Lidocaine

Placebo DRUG

Dextrose 5% 100mL over 10 minutes

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years old with sickle cell disease experiencing persistent severe (7-10/10) pain despite receiving at least one dose of intravenous opiate analgesic.

You may not qualify if:

• Patients \< 18 years old and pregnant
• Patients presenting with or suspected to have acute chest syndrome
• Allergy or intolerance to lidocaine products or morphine/hydromorphone

Sponsors & Collaborators

• Community Medical Center, Toms River, NJ: lead
• Newark Beth Israel Medical Center: collaborator
• Monmouth Medical Center: collaborator
• Rutgers Robert Wood Johnson Medical School: collaborator

Study Sites (3)

Monmouth Medical Center

Long Branch, New Jersey, 07740, United States

Location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Related Publications (13)

• E Silva LOJ, Scherber K, Cabrera D, Motov S, Erwin PJ, West CP, Murad MH, Bellolio MF. Safety and Efficacy of Intravenous Lidocaine for Pain Management in the Emergency Department: A Systematic Review. Ann Emerg Med. 2018 Aug;72(2):135-144.e3. doi: 10.1016/j.annemergmed.2017.12.014. Epub 2018 Feb 1.

  PMID: 29395284 BACKGROUND

• Lanzkron S, Carroll CP, Haywood C Jr. The burden of emergency department use for sickle-cell disease: an analysis of the national emergency department sample database. Am J Hematol. 2010 Oct;85(10):797-9. doi: 10.1002/ajh.21807.

  PMID: 20730795 BACKGROUND

• Payne J, Aban I, Hilliard LM, Madison J, Bemrich-Stolz C, Howard TH, Brandow A, Waite E, Lebensburger JD. Impact of early analgesia on hospitalization outcomes for sickle cell pain crisis. Pediatr Blood Cancer. 2018 Dec;65(12):e27420. doi: 10.1002/pbc.27420. Epub 2018 Aug 27.

  PMID: 30151977 BACKGROUND

• Lexicomp Online, Lexi-Drugs Online, Hudson, Ohio: Lexi-Comp, Inc.; December 15, 2017.

  BACKGROUND

• Eipe N, Gupta S, Penning J. Intravenous Lidocaine for Acute Pain: an Evidence-based Clinical Update. BJA Education,16(9):292-298(2016). Doi: 10.1093/bjaed/mkw008

  BACKGROUND

• Carroll CP, Lanzkron S, Haywood C Jr, Kiley K, Pejsa M, Moscou-Jackson G, Haythornthwaite JA, Campbell CM. Chronic Opioid Therapy and Central Sensitization in Sickle Cell Disease. Am J Prev Med. 2016 Jul;51(1 Suppl 1):S69-77. doi: 10.1016/j.amepre.2016.02.012.

  PMID: 27320469 BACKGROUND

• Nguyen NL, Kome AM, Lowe DK, Coyne P, Hawks KG. Intravenous Lidocaine as an Adjuvant for Pain Associated with Sickle Cell Disease. J Pain Palliat Care Pharmacother. 2015;29(4):359-64. doi: 10.3109/15360288.2015.1082009.

  PMID: 26654408 BACKGROUND

• Rousseau V, Morelle M, Arriuberge C, Darnis S, Chabaud S, Launay V, Thouvenin S, Roumenoff-Turcant F, Metzger S, Tourniaire B, Marec-Berard P. Efficacy and Tolerance of Lidocaine 5% Patches in Neuropathic Pain and Pain Related to Vaso-occlusive Sickle Cell Crises in Children: A Prospective Multicenter Clinical Study. Pain Pract. 2018 Jul;18(6):788-797. doi: 10.1111/papr.12674. Epub 2018 Feb 28.

  PMID: 29266772 BACKGROUND

• 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.

  PMID: 22559856 BACKGROUND

• 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.

  PMID: 26704774 BACKGROUND

• Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003 Apr;10(4):390-2. doi: 10.1111/j.1553-2712.2003.tb01355.x.

  PMID: 12670856 BACKGROUND

• Holdgate A, Asha S, Craig J, Thompson J. Comparison of a verbal numeric rating scale with the visual analogue scale for the measurement of acute pain. Emerg Med (Fremantle). 2003 Oct-Dec;15(5-6):441-6. doi: 10.1046/j.1442-2026.2003.00499.x.

  PMID: 14992058 BACKGROUND

• Motov 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.

  PMID: 30770244 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises; Acute Pain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shreni Zinzuwadia, MD

  Newark Beth Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew V Vassallo, PharmD

CONTACT

732-557-8070; Andrew.Vassallo@rwjbh.org

Shreni Zinzuwadia, MD

CONTACT

zinzuwsh@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Lidocaine or placebo will be dispensed from the pharmacy in identical bags labeled "Lidocaine (x)mg or Placebo". The pharmacy will maintain randomization and blinding until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Research Coordinator

Model Details: Patients presenting to the emergency department for an acute sickle cell crisis who are refractory to one dose of intravenous opiate therapy will be randomized to either lidocaine 1.5mg/kg (max: 200mg) or matching dextrose placebo along with either morphine 0.1-0.15mg/kg IV or hydromorphone 0.01-0.02mg/kg IV.

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 4, 2020
• Study Start: January 1, 2024
• Primary Completion: January 2, 2025
• Study Completion: June 1, 2025
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

US (3)