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Phase 4 N=150 Randomized Quadruple-blind Treatment

Intravenous Lidocaine and Ketorolac for Pain Management

Pain

Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Pain Score at 30 Minutes — 5.52; 3.88; 3.14 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Lidocaine (Drug); Ketorolac Tromethamine (Drug); Normal Saline Drip (Drug); Normal Saline Push (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Antonios Likourezos
Primary completion
Oct 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Pain Score at 30 Minutes
5.52; 3.88; 3.14

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.

Eligibility Criteria

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 150
  • history of cardiac arrhythmias
  • peritonitis or presence of any peritoneal sign
  • altered mental status
  • weight > 100kg
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02902770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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