Intravenous Lidocaine and Ketorolac for Pain Management

March 11, 2020 updated by: Antonios Likourezos

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators designed a double-blind, randomized, clinical trial to evaluate analgesic efficacy, safety and feasibility of non-opioid analgesics IV Lidocaine and IV Ketorolac and combination of both in patients with renal colic. The hypothesis and proposed study will try to determine if a combination of IV lidocaine and IV ketorolac is superior to either drug alone and if this non-opioid analgesic combination is effective for controlling pain of renal colic origin. The trial will compare pain scores at 15 min and 30 min between and within the three treatment groups of the study: IV ketorolac 30mg push and 10 minute normal saline drip placebo, 1.5mg/kg IV lidocaine drip (given over 10 minutes) and normal saline push placebo, or IV ketorolac push and IV lidocaine drip.

Once a patient is enrolled, the on duty ED pharmacist will prepare any one of the three treatment groups based on a predetermined randomization list generated via SPSS 19.0.The study investigators will record pain scores, vital signs, and side effects at baseline, 15, 30 and 60 minutes post-medication administration. If the patient still reports pain of five or greater and requests additional pain relief then morphine at 0.1mg/kg will be given as the rescue analgesic. Blinding of medication from the patient, research team, and staff will be strictly maintained by the pharmacist investigators.

Sample Size Calculation:

Fifty per group or 150 is needed given a standard 1.3 as the minimum clinically significant score and 3.0 as our standard deviation at 80% power and a=.05.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 62 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Emergency Medicine Patient
  • clinical diagnosis of acute renal colic
  • pain score of >=5 out of 10 on the numeric rating scale
  • - age 18 - 64 years of age

Exclusion Criteria:

  • documented or suspected pregnancy, breastfeeding
  • contraindication to nonsteroidal anti-inflammatory drugs or lidocaine
  • known renal dysfunction
  • received analgesics within 4 hours before presentation
  • history of bleeding diathesis
  • history of peptic ulcer disease
  • current use of warfarin
  • HR<50 or >150
  • history of cardiac arrhythmias
  • peritonitis or presence of any peritoneal sign
  • altered mental status
  • weight > 100kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine and normal saline push
1.5mg/kg IV Lidocaine Drip (given over 10 minutes) and normal saline push
Drug: Lidocaine
1.5 mg/kg IV lidocaine drip (given over 10 minutes)
Other Names:
  • Xylocaine
Drug: Normal Saline Push
Normal Saline Push Placebo
Other Names:
  • Normal Saline
Active Comparator: Ketorolac and normal saline drip
IV Ketorolac Tromethamine 30mg push and 10 minute normal saline drip
Drug: Ketorolac Tromethamine
IV ketorolac 30mg push
Other Names:
  • Toradol
Drug: Normal Saline Drip
Normal Saline Drip Placebo given over 10 minutes
Other Names:
  • Normal Saline
Active Comparator: Lidocaine and Ketorolac
IV Lidocaine Drip and IV Ketorolac Push
Drug: Lidocaine
1.5 mg/kg IV lidocaine drip (given over 10 minutes)
Other Names:
  • Xylocaine
Drug: Ketorolac Tromethamine
IV ketorolac 30mg push
Other Names:
  • Toradol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score at 30 Minutes
Time Frame: 30 minutes
The trial will compare the patient's pain score on a 11 point Likert scale, ranging from 0 to 10 with 0 being no pain, 5 moderate pain and 10 very severe pain, at 30 minutes
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antonios Likourezos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

October 4, 2018

Study Completion (Actual)

September 10, 2019

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-03-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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