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

Phase 4

Terminated

Conditions: Abdominal Pain
Renal Colic

Interventions: Drug: HYDROmorphone Injection
Drug: Lidocaine Iv

Registration Number: NCT04398316

Lead Sponsor: Hennepin Healthcare Research Institute

Brief 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 4

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous Hydromorphone	HYDROmorphone Injection	Administered at a dose of 1 mg over 5 minutes
Intravenous Lidocaine	Lidocaine Iv	Administered at a dose of 2 mg/kg over 5 minutes

Primary Outcome Measures

Name	Time	Method
Mean Improvement in Pain at 90 Minutes	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).

Secondary Outcome Measures

Name	Time	Method
Improvement in Numerical Pain Score at 30 Minutes	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).
Sufficient Pain Relief	From administration of study drug until patient leaves the emergency department, up until 3 hours from administration of study drug.	Does the patient require off-protocol medication for additional pain relief? Off-protocol defined as any opiate or NSAID
Improvement in Numerical Pain Score at 15 Minutes	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).
Improvement in Numerical Pain Score at 120 Minutes	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).
Improvement in Numerical Pain Score at 150 Minutes	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).
Improvement in Numerical Pain Score at 180 Minutes	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).
Patient Preference for the Medication They Received	Day 7	If the patient were to come to the ED again for the same complaint, would they want the same study drug they received?
Side Effects	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	Yes or no, did the patient have any side effects, defined as any new symptom after the administration of the study drug.
Medication for Side Effects	15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and 180 minutes	Are any medications required to control medication side effects, defined as any new symptom after the administration of the study drug?
Administration of Naloxone	15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and at 180 minutes	Yes or no, was naloxone required after the patient received the study drug?
Change in Disposition	15 minutes after administration of study drug then again at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes and at 180 minutes	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.
Missed Diagnosis	7 days after administration of study drug	Yes or no, did the patient have a new diagnosis within the next week?
Serious Adverse Event	180 minutes after administration of study drug	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.
Improvement in Numerical Pain Score at 60 Minutes	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).