CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 150 enrolled
Drug / intervention
Lidocaine +3 moredrug
Likely dose
Lidocaine 1.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02902770
NCT02902770Phase 4Completed

A Randomized Trial Comparing the Combination of Intravenous Lidocaine and Ketorolac to Either Analgesics Alone for ED Patients With Acute Renal Colic

Antonios Likourezos·interventional·Posted Sep 16, 2016·Updated Mar 18, 2020

In Brief

A Phase 4 clinical trial evaluating Lidocaine, Ketorolac Tromethamine, and 2 other interventions for Pain. Completed, enrolled 150 participants.

Detailed Summary

The literature regarding analgesic modalities, their combinations and routes of administrations for patients with pain related to renal colic is expanding. NSAID's (IV ketorolac) and opioids (morphine) constitutes the mainstay of treatment of renal colic either alone or in combinations. Despite their synergism and analgesic superiority when administered together, both classes of these medications possess a set of unfavorable side effects that limit their use. Emerging data of the use of IV lidocaine for patients with renal colic demonstrated good analgesic efficacy and safety profile. However, none of the trials directly compared lidocaine to ketorolac or the combination of both as viable options in patients unable to tolerate or to have serious contraindications to opioids. We designed a double-blinded, randomized, controlled trial to evaluate analgesic efficacy, safety and feasibility of non-opioid analgesics and their combinations in patients with renal colic. The hypothesis and proposed study will try to determine if a combination of IV lidocaine and reduced dose of IV ketorolac is superior to either drug alone and if this non-opioid analgesic modality is effective for controlling pain of renal colic origin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 16, 2016
Enrollment StartOct 1, 2016
Primary CompletionOct 4, 2018
Study CompletionSep 10, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.8 years ago

Interventions

Lidocainedrug

1.5 mg/kg IV lidocaine drip (given over 10 minutes)

Ketorolac Tromethaminedrug

IV ketorolac 30mg push

Normal Saline Dripdrug

Normal Saline Drip Placebo given over 10 minutes

Normal Saline Pushdrug

Normal Saline Push Placebo