drugset / Trial / NCT02902770

Intravenous Lidocaine and Ketorolac for Pain Management

NCT02902770

Phase 4 Completed 150 enrolled Antonios Likourezos
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

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

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ketorolac Tromethamine Small molecule 30 mg Intravenous
Comparator Lidocaine Other / unclassified 1.5 mg/kg Intravenous

Indications

No indication recorded.