MedTrace Logo

Intravenous Lidocaine and Ketorolac for Pain Management

NCT02902770 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-03-18

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Lidocaine

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

DRUG

Ketorolac Tromethamine

IV ketorolac 30mg push

DRUG

Normal Saline Drip

Normal Saline Drip Placebo given over 10 minutes

DRUG

Normal Saline Push

Normal Saline Push Placebo

Sponsors & Collaborators

  • Antonios Likourezos

    lead OTHER

Principal Investigators

  • Sergey Motov, MD · Maimonides Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-10-04
Completion
2019-09-10

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02902770 on ClinicalTrials.gov