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Phase 4 Completed N=154 Randomized Quadruple-blind Treatment

Intravenous Lidocaine Randomized Comparative Effectiveness Trial

Source: ClinicalTrials.gov NCT03300674 ↗
Enrolled (actual)
154
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Change in 0-10 Pain Scale Between Baseline and 90 Minutes — 5.0; 3.8 units on a scale

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in 0-10 Pain Scale Between Baseline and 90 Minutes
5.0; 3.8
SECONDARY
Rescue Medication
20; 39
SECONDARY
Adverse Events
28; 23

Eligibility Criteria

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 120kg will be excluded. -
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03300674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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