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OpenTrials
Completed

NCT Number: NCT02902770

Intravenous Lidocaine and Ketorolac for Pain Management

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

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

Other names: Xylocaine

Ketorolac Tromethamine

Drug

IV ketorolac 30mg push

Other names: Toradol

Normal Saline Drip

Drug

Normal Saline Drip Placebo given over 10 minutes

Other names: Normal Saline

Normal Saline Push

Drug

Normal Saline Push Placebo

Other names: Normal Saline

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Antonios Likourezos

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 16, 2016
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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