Sickle Cell DiseasePhase 2RELIEF-SCCNCT04614610
Lidocaine Intravenous in the Emergency Department For Sickle Cell Crisis
A Phase 2 study testing Lidocaine Iv in people with Sickle Cell Disease and Sickle Cell Crisis, run by Community Medical Center, Toms River, NJ at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease, Sickle Cell Crisis, Pain, Acute
- What is being tested?
- Lidocaine Iv
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2024to 1 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Shreni Zinzuwadia, MD contact
United States3 sites
Monmouth Medical Center
Long Branch, New Jersey, 07740
Harisios Tjionas, MD, harisios.tjionas@gmail.com
Nicole Keegan, DNP, Nicole.Keegan@rwjbh.org
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
John Collins, MD, collinjj@rwjms.rutgers.edu
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Shreni Zinzuwadia, MD, zinzuwsh@gmail.com
Patrick Hinfey, MD, Patrick.Hinfey@rwjbh.org
About this study
Official title: Randomized Trial Evaluating Lidocaine Intravenous in the Emergency Department For Sickle Cell Crisis - RELIEF-SCC
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.
Read the detailed description
Pain is the most frequent reason for emergency department visits in the United States, especially for those patients with sickle cell disease (SCD). Painful vaso-occlusive events frequently require admission to the hospital despite opioid therapy, which is the mainstay of treatment for moderate to severe pain in SCD. Achieving adequate pain control with escalating doses of opioid analgesics may be difficult due to tolerance, physical dependence, and side effects. Common side effects include pruritus, nausea and vomiting, constipation, urinary retention, sedation, and respiratory depression. With the recent focus on the opiate crisis there has been a push towards the use of alternative to opiates (ALTO) for a variety of pain syndromes.
Lidocaine is a class 1b sodium channel blocking agent that is typically used as an anti-arrhythmic and local anesthetic. This medication also has potent anti-inflammatory, anti-hyperalgesic, and gastrointestinal pro-peristaltic properties. Lidocaine may be useful as an adjunct to opioids in response to a painful sickle cell crisis. Intravenous (IV) lidocaine infusion has previously shown benefit in neuropathic pain, renal colic, and peri-operative pain. No prospective studies have evaluated lidocaine for SCD pain thus far.
A previous retrospective study evaluated lidocaine infusion as adjuvant therapy to patients with SCD. Eleven patients were given a total of 15 IV lidocaine trials. Investigators found clinical improvement in pain score from pre-lidocaine challenge to 24 hours post (defined as a >20% reduction in pain scores) in 53.3% (8 of 15) of patients. Of the 8 clinically successful trials, the mean reduction in morphine dose equivalents (MDE) from 24 hours pre to 24 hours post lidocaine was 32.2%. Two patients experienced disorientation and dizziness. The authors concluded that lidocaine was able to provide pain relief and reduce the amount of morphine necessary during SCD vaso-occlusive crisis and that prospective studies are needed to determine its true efficacy, dosing, and tolerability.
A prospective, single-arm, phase II trial evaluated lidocaine 5% patches for neuropathic pain and pain related to vaso-occlusive sickle cell crises in children ages 6 to 21 years old. Patches were applied to the painful area for 12 hours a day. The primary endpoint was the proportion of inpatients with significant pain relief defined as a decrease of at least 2 points on the visual analog pain scale (VAS, from 0-10) measured at 12 hours after patch placement over two consecutive days. The use of additional treatments such as antiepileptics and opioids were allowed and their usage was documented. The primary outcome of VAS improvement of >2 over 2 consecutive days was observed in 48.6% of evaluated patients (19/39). Transdermal lidocaine was tolerated well with only 3 minor adverse events reported (two localized skin reactions and one generalized skin eruption) and no serious adverse events.
The theoretical benefits along with the two previously discussed studies provide evidence to further investigate the use of lidocaine in SCD pain. Studies are needed to know whether lidocaine may be able to benefit alleviate pain quicker and minimize need for opiates similarly to its use in renal colic. This prospective trial aims to evaluate whether lidocaine can decrease the opiate needs during a SCD crisis while providing adequate pain relief and tolerability.
- Conditions
- Sickle Cell Disease, Sickle Cell Crisis, Pain, Acute
- Being tested
- Lidocaine Iv, Placebo
- Keywords
- lidocaine, ALTO, sickle cell pain
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine IvDrug
Lidocaine 1.5mg/kg (Max dose: 200mg) in Dextrose 5% 100mL over 10 minutes
PlaceboDrug
Dextrose 5% 100mL over 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain at 30 minutes
Change of visual analog pain scale (VAS, 0-10) at 30 minutes post-infusion of lidocaine or placebo.
Measured: from pre-lidocaine infusion to 30 minutes post-infusion
Secondary outcomes (8)
Total opiate dosage received
Total morphine mg equivalents (MME) of opiate received normalized to patient's bodyweight during their ED stay.
Measured: from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)
% Patients requiring additional opiate administration
Percentage of patients requiring an additional opiate after the lidocaine vs. placebo.
Measured: from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)
Time to next opiate administered
Time (minutes) until next opiate is administered after lidocaine vs. placebo.
Measured: from administration of lidocaine infusion until patient disposition (up to 12 hours) or next opiate administered
Total MME post-lidocaine up to 12 hours
Total MME needed after lidocaine vs placebo up to 12 hours
Measured: 12 hours post-lidocaine or placebo infusion.
Percentage of patients discharged from ED
Percentage of patients discharged from the ED.
Measured: from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)
Percentage of patients receiving a >20% reduction in pain scale
Percentage of patients receiving a >20% reduction in pain scale based on the VAS (0-10).
Measured: from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)
Change in visual analog pain scale (VAS, 0-10 with 10 being the most pain) at 60 and 90 minutes
Change in VAS at 60 and 90 minutes post-infusion.
Measured: 60 and 90 minutes
Number of adverse effects of treatment
Reported adverse effects during study treatment period
Measured: from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Jan 2024 (estimated)
- Primary completion2 Jan 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Community Medical Center, Toms River, NJ
- Sponsor type
- University, hospital or other
- Collaborators
- Newark Beth Israel Medical Center, Monmouth Medical Center, Rutgers Robert Wood Johnson Medical School
- Responsible party
- Principal investigator, Andrew Vassallo, Community Medical Center, Toms River, NJ
- Investigators
- Shreni Zinzuwadia, MD, Principal investigator, Newark Beth Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614610
- Sponsor's protocol ID
- 20-58
- Acronym
- RELIEF-SCC
- Status last verified
- Aug 2023
- First submitted
- 22 Oct 2020
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29395284Lanzkron 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.
PubMed 20730795Payne 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.
PubMed 30151977Lexicomp Online, Lexi-Drugs Online, Hudson, Ohio: Lexi-Comp, Inc.; December 15, 2017.
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
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.
PubMed 27320469Nguyen 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.
PubMed 26654408Rousseau 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.
PubMed 29266772Soleimanpour 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 26704774Bijur 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.
PubMed 12670856Holdgate 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.
PubMed 14992058Motov 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 30770244
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Evaluating Lidocaine Intravenous in the Emergency Department For Sickle Cell Crisis - RELIEF-SCC
- ClinicalTrials.gov ID
- NCT04614610
- Acronym / sponsor ID
- RELIEF-SCC / 20-58
- Conditions
- Sickle Cell Disease, Sickle Cell Crisis, Pain, Acute
- Keywords
- lidocaine, ALTO, sickle cell pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Community Medical Center, Toms River, NJUniversity, hospital or other
- Collaborators
- Newark Beth Israel Medical Center, Monmouth Medical Center, Rutgers Robert Wood Johnson Medical School
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 2 Jan 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 4 Nov 2020 (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.
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.
Detailed description
Pain is the most frequent reason for emergency department visits in the United States, especially for those patients with sickle cell disease (SCD). Painful vaso-occlusive events frequently require admission to the hospital despite opioid therapy, which is the mainstay of treatment for moderate to severe pain in SCD. Achieving adequate pain control with escalating doses of opioid analgesics may be difficult due to tolerance, physical dependence, and side effects. Common side effects include pruritus, nausea and vomiting, constipation, urinary retention, sedation, and respiratory depression. With the recent focus on the opiate crisis there has been a push towards the use of alternative to opiates (ALTO) for a variety of pain syndromes.
Lidocaine is a class 1b sodium channel blocking agent that is typically used as an anti-arrhythmic and local anesthetic. This medication also has potent anti-inflammatory, anti-hyperalgesic, and gastrointestinal pro-peristaltic properties. Lidocaine may be useful as an adjunct to opioids in response to a painful sickle cell crisis. Intravenous (IV) lidocaine infusion has previously shown benefit in neuropathic pain, renal colic, and peri-operative pain. No prospective studies have evaluated lidocaine for SCD pain thus far.
A previous retrospective study evaluated lidocaine infusion as adjuvant therapy to patients with SCD. Eleven patients were given a total of 15 IV lidocaine trials. Investigators found clinical improvement in pain score from pre-lidocaine challenge to 24 hours post (defined as a >20% reduction in pain scores) in 53.3% (8 of 15) of patients. Of the 8 clinically successful trials, the mean reduction in morphine dose equivalents (MDE) from 24 hours pre to 24 hours post lidocaine was 32.2%. Two patients experienced disorientation and dizziness. The authors concluded that lidocaine was able to provide pain relief and reduce the amount of morphine necessary during SCD vaso-occlusive crisis and that prospective studies are needed to determine its true efficacy, dosing, and tolerability.
A prospective, single-arm, phase II trial evaluated lidocaine 5% patches for neuropathic pain and pain related to vaso-occlusive sickle cell crises in children ages 6 to 21 years old. Patches were applied to the painful area for 12 hours a day. The primary endpoint was the proportion of inpatients with significant pain relief defined as a decrease of at least 2 points on the visual analog pain scale (VAS, from 0-10) measured at 12 hours after patch placement over two consecutive days. The use of additional treatments such as antiepileptics and opioids were allowed and their usage was documented. The primary outcome of VAS improvement of >2 over 2 consecutive days was observed in 48.6% of evaluated patients (19/39). Transdermal lidocaine was tolerated well with only 3 minor adverse events reported (two localized skin reactions and one generalized skin eruption) and no serious adverse events.
The theoretical benefits along with the two previously discussed studies provide evidence to further investigate the use of lidocaine in SCD pain. Studies are needed to know whether lidocaine may be able to benefit alleviate pain quicker and minimize need for opiates similarly to its use in renal colic. This prospective trial aims to evaluate whether lidocaine can decrease the opiate needs during a SCD crisis while providing adequate pain relief and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: Lidocaine IvLidocaine 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. |
| Placebo | Placebo comparator | Drug: PlaceboDextrose 5% 100mL (placebo) over 10 minutes along with either morphine 0.1-0.15mg/kg IV OR hydromorphone 0.01-0.02mg/kg IV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 IvLidocaine 1.5mg/kg (Max dose: 200mg) in Dextrose 5% 100mL over 10 minutes | Drug | Lidocaine |
| PlaceboDextrose 5% 100mL over 10 minutes | Drug | Placebo |
Primary outcome
Change in pain at 30 minutes
Time frame: from pre-lidocaine infusion to 30 minutes post-infusion
Change of visual analog pain scale (VAS, 0-10) at 30 minutes post-infusion of lidocaine or placebo.
8 secondary outcomes
Total opiate dosage received
Time frame: from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)
% Patients requiring additional opiate administration
Time frame: from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)
Time to next opiate administered
Time frame: from administration of lidocaine infusion until patient disposition (up to 12 hours) or next opiate administered
Total MME post-lidocaine up to 12 hours
Time frame: 12 hours post-lidocaine or placebo infusion.
Percentage of patients discharged from ED
Time frame: from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)
Percentage of patients receiving a >20% reduction in pain scale
Time frame: from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)
Change in visual analog pain scale (VAS, 0-10 with 10 being the most pain) at 60 and 90 minutes
Time frame: 60 and 90 minutes
Number of adverse effects of treatment
Time frame: from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Background: PubMed 29395284E 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.
- Background: PubMed 20730795Lanzkron 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.
- Background: PubMed 30151977Payne 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.
- BackgroundLexicomp Online, Lexi-Drugs Online, Hudson, Ohio: Lexi-Comp, Inc.; December 15, 2017.
- BackgroundEipe 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: PubMed 27320469Carroll 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.
- Background: PubMed 26654408Nguyen 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.
- Background: PubMed 29266772Rousseau 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.
- 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 12670856Bijur 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.
- Background: PubMed 14992058Holdgate 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.
- Individual participant dataSharing planned: Undecided
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Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
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.
Shreni Zinzuwadia, MD contact
Shreni Zinzuwadia, MD principal investigator
Newark Beth Israel
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine Iv in people with Sickle Cell Disease and Sickle Cell Crisis, run by Community Medical Center, Toms River, NJ at 3 sites 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew V Vassallo, PharmD (732-557-8070, Andrew.Vassallo@rwjbh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain at 30 minutes (time frame: from pre-lidocaine infusion to 30 minutes post-infusion). 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 NCT04614610, 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 29 Aug 2023.