Intravenous Lidocaine Randomized Comparative Effectiveness Trial

Phase 4

Completed

Conditions: Abdominal Pain

Interventions: Drug: Lidocaine
Drug: Hydromorphone

Registration Number: NCT03300674

Lead Sponsor: Montefiore Medical Center

Brief Summary: This is a randomized, double-blind, emergency department based, comparative effectiveness study of two medication for acute abdominal pain: intravenous lidocaine and intravenous hydromorphone. Patients will be enrolled during an emergency department visit and followed throughout their emergency department course and then by telephone 7 days later.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 154

Inclusion Criteria

Eligible patients are those who present to an ED for treatment of acute abdominal pain. Acute will be defined as pain for no more than seven days. At the time of enrollment, the ED treatment plan must include use of an intravenous opioid.

Exclusion Criteria

Patients will be excluded from participation if they have cardiac conduction system impairment (QTc duration > 0.5s, QRS duration > 0.12s, or PR interval duration > 0.2s), known renal (CKD >2) or liver disease (Childs-Pugh B or greater), are hemodynamically unstable, as determined by the attending physician, are pregnant or breastfeeding, or have a known allergy to either medication. Patients will also be excluded if they have used prescription or illicit opioids within the previous week, or if they have a chronic pain disorder, defined as use of any analgesic medication on more days than not during the month preceding the acute episode of pain. Patients weighing < 60kg or > 120kg will be excluded.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous lidocaine	Lidocaine	Intravenous lidocaine 120 mg. A second dose can be administered at 30 minutes
Intravenous hydromorphone	Hydromorphone	Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.

Primary Outcome Measures

Name	Time	Method
Change in 0-10 Pain Scale Between Baseline and 90 Minutes	up to 90 minutes	Participants were asked to describe their pain on a scale from 0 to 10 with 0= no pain and 10= the worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
Rescue Medication	4 hours	no need for off-protocol parenteral pain medication during the ED visit. The following parenteral medications will be considered off protocol pain medication: any opioid, any non-steroidal anti-inflammatory drug
Adverse Events	4 hours	Any new symptom development after administration of investigational medication