Completed

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

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What is being tested

Lidocaine

+ Ketorolac Tromethamine

+ Normal Saline Push

Drug
Who is being recruted

Neurologic Manifestations+1

+ Pain

+ Signs and Symptoms

From 18 to 64 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: October 2016
See protocol details

Summary

Principal SponsorAntonios Likourezos
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleA Randomized Trial Comparing the Combination of Intravenous Lidocaine and Ketorolac to Either Analgesics Alone for ED Patients With Acute Renal Colic
NCT02902770
Principal SponsorAntonios Likourezos
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 64 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

4 inclusion criteria required to participate
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

12 exclusion criteria prevent from participating
history of bleeding diathesis

documented or suspected pregnancy, breastfeeding

contraindication to nonsteroidal anti-inflammatory drugs or lidocaine

known renal dysfunction

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
IV Lidocaine Drip and IV Ketorolac Push

Group II

Active Comparator
1.5mg/kg IV Lidocaine Drip (given over 10 minutes) and normal saline push

Group III

Active Comparator
IV Ketorolac Tromethamine 30mg push and 10 minute normal saline drip

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers