A Phase 2 interventional study of Lidocaine Iv and Placebo in Sickle Cell Disease, Sickle Cell Crisis and Pain, Acute, sponsored by Community Medical Center, Toms River, NJ. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-29.
Sponsored by Community Medical Center, Toms River, NJ · Phase 2, Interventional, and Treatment
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.
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.
1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Community Medical Center, Toms River, NJ is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
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
Lidocaine 1.5mg/kg (Max dose: 200mg) in Dextrose 5% 100mL over 10 minutes
Dextrose 5% 100mL over 10 minutes
Change in pain at 30 minutes
Change of visual analog pain scale (VAS, 0-10) at 30 minutes post-infusion of lidocaine or placebo.
Time frame: from pre-lidocaine infusion to 30 minutes post-infusion
Total opiate dosage received
Total morphine mg equivalents (MME) of opiate received normalized to patient's bodyweight during their ED stay.
Time frame: 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.
Time frame: 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.
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
Total MME needed after lidocaine vs placebo up to 12 hours
Time frame: 12 hours post-lidocaine or placebo infusion.
Percentage of patients discharged from ED
Percentage of patients discharged from the 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
Percentage of patients receiving a \>20% reduction in pain scale based on the VAS (0-10).
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
Change in VAS at 60 and 90 minutes post-infusion.
Time frame: 60 and 90 minutes
Number of adverse effects of treatment
Reported adverse effects during study treatment period
Time frame: from presentation to the Emergency department (ED) until patient disposition (up to 12 hours)
Plan to share: Undecided
Start is estimated for Jan 2024; primary completion for Jan 2025, 12 months later.
Of 58 non-industry phase 2 interventional studies under Anemia, Sickle Cell, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 117. This study's planned 12 months is below that.
Counting every sponsor, half of 92 studies reached it within 46 months; a quarter within 24 and three quarters within 73.
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This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
Community Medical Center, Toms River, NJ