Trial Outcomes & Findings for Intravenous Lidocaine and Ketorolac for Pain Management (NCT NCT02902770)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

150 participants

Primary outcome timeframe

30 minutes

Results posted on

2020-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	Lidocaine and Normal Saline Push 1.5mg/kg IV Lidocaine Drip (given over 10 minutes) and normal saline push Lidocaine: 1.5 mg/kg IV lidocaine drip (given over 10 minutes) Normal Saline Push: Normal Saline Push Placebo	Ketorolac and Normal Saline Drip IV Ketorolac Tromethamine 30mg push and 10 minute normal saline drip Ketorolac Tromethamine: IV ketorolac 30mg push Normal Saline Drip: Normal Saline Drip Placebo given over 10 minutes	Lidocaine and Ketorolac IV Lidocaine Drip and IV Ketorolac Push Lidocaine: 1.5 mg/kg IV lidocaine drip (given over 10 minutes) Ketorolac Tromethamine: IV ketorolac 30mg push
Overall Study STARTED	50	50	50
Overall Study COMPLETED	50	50	50
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine and Normal Saline Push n=50 Participants 1.5mg/kg IV Lidocaine Drip (given over 10 minutes) and normal saline push Lidocaine: 1.5 mg/kg IV lidocaine drip (given over 10 minutes) Normal Saline Push: Normal Saline Push Placebo	Ketorolac and Normal Saline Drip n=50 Participants IV Ketorolac Tromethamine 30mg push and 10 minute normal saline drip Ketorolac Tromethamine: IV ketorolac 30mg push Normal Saline Drip: Normal Saline Drip Placebo given over 10 minutes	Lidocaine and Ketorolac n=50 Participants IV Lidocaine Drip and IV Ketorolac Push Lidocaine: 1.5 mg/kg IV lidocaine drip (given over 10 minutes) Ketorolac Tromethamine: IV ketorolac 30mg push	Total n=150 Participants Total of all reporting groups
Age, Continuous	39.3 years STANDARD_DEVIATION 11.0 • n=50 Participants	42.3 years STANDARD_DEVIATION 10.5 • n=50 Participants	41.9 years STANDARD_DEVIATION 10.4 • n=50 Participants	41.9 years STANDARD_DEVIATION 10.7 • n=150 Participants
Sex: Female, Male Female	23 Participants n=50 Participants	22 Participants n=50 Participants	22 Participants n=50 Participants	67 Participants n=150 Participants
Sex: Female, Male Male	27 Participants n=50 Participants	28 Participants n=50 Participants	28 Participants n=50 Participants	83 Participants n=150 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	50 participants n=50 Participants	50 participants n=50 Participants	50 participants n=50 Participants	150 participants n=150 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Lidocaine and Normal Saline Push n=50 Participants 1.5mg/kg IV Lidocaine Drip (given over 10 minutes) and normal saline push Lidocaine: 1.5 mg/kg IV lidocaine drip (given over 10 minutes) Normal Saline Push: Normal Saline Push Placebo	Ketorolac and Normal Saline Drip n=50 Participants IV Ketorolac Tromethamine 30mg push and 10 minute normal saline drip Ketorolac Tromethamine: IV ketorolac 30mg push Normal Saline Drip: Normal Saline Drip Placebo given over 10 minutes	Lidocaine and Ketorolac n=50 Participants IV Lidocaine Drip and IV Ketorolac Push Lidocaine: 1.5 mg/kg IV lidocaine drip (given over 10 minutes) Ketorolac Tromethamine: IV ketorolac 30mg push
Pain Score at 30 Minutes	5.52 score on a scale Standard Deviation 3.07	3.88 score on a scale Standard Deviation 2.92	3.14 score on a scale Standard Deviation 2.61

Adverse Events

Lidocaine and Normal Saline Push

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ketorolac and Normal Saline Drip

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lidocaine and Ketorolac

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Antonios Likourezos

Maimonides Medical Center

Phone: 7182836896

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place