Trial Outcomes & Findings for A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management (NCT NCT02078492)

Results Overview

Pain score of each group at 30 minutes. The Numeric Rating Pain (NRS) scale was used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). A score of 5 is moderate pain. The higher the pain score the higher the pain severity.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

240 participants

Primary outcome timeframe

30 minutes

Results posted on

2017-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 - 10 mg of Ketorolac Subjects will be administered 10 mg of Ketorolac for pain relief. 10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control.	Group 2 - 15mg Subjects will be administered 15mg of Ketorolac. 15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.	Group 3 - 30mg Subject will receive 30mg of Ketorolac as a part of standard care. 30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control.
Overall Study STARTED	80	80	80
Overall Study COMPLETED	80	80	80
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 - 10 mg of Ketorolac n=80 Participants Subjects will be administered 10 mg of Ketorolac for pain relief. 10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control.	Group 2 - 15mg n=80 Participants Subjects will be administered 15mg of Ketorolac. 15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.	Group 3 - 30mg n=80 Participants Subject will receive 30mg of Ketorolac as a part of standard care. 30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control.	Total n=240 Participants Total of all reporting groups
Age, Continuous	41.5 years STANDARD_DEVIATION 12.1 • n=5 Participants	40.1 years STANDARD_DEVIATION 12.1 • n=7 Participants	38.8 years STANDARD_DEVIATION 11.6 • n=5 Participants	40.2 years STANDARD_DEVIATION 11.9 • n=4 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	48 Participants n=7 Participants	43 Participants n=5 Participants	132 Participants n=4 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	32 Participants n=7 Participants	37 Participants n=5 Participants	108 Participants n=4 Participants
Region of Enrollment United States	80 participants n=5 Participants	80 participants n=7 Participants	80 participants n=5 Participants	240 participants n=4 Participants

PRIMARY outcome

Timeframe: 30 minutes

Pain score of each group at 30 minutes. The Numeric Rating Pain (NRS) scale was used for the study. The NRS ranges from 0 (no pain) to 10 (very severe pain). A score of 5 is moderate pain. The higher the pain score the higher the pain severity.

Outcome measures

Outcome measures
Measure	Group 1 - 10 mg of Ketorolac n=80 Participants Subjects will be administered 10 mg of Ketorolac for pain relief. 10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control.	Group 2 - 15mg n=80 Participants Subjects will be administered 15mg of Ketorolac. 15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.	Group 3 - 30mg n=80 Participants Subject will receive 30mg of Ketorolac as a part of standard care. 30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control.
Pain Score at 30 Minutes	5.14 pain score Standard Deviation 2.70	5.05 pain score Standard Deviation 2.56	4.81 pain score Standard Deviation 2.85

SECONDARY outcome

Timeframe: 120 minutes

the number of study patients who reported having dizziness after administration of medication.

Outcome measures

Outcome measures
Measure	Group 1 - 10 mg of Ketorolac n=80 Participants Subjects will be administered 10 mg of Ketorolac for pain relief. 10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control.	Group 2 - 15mg n=80 Participants Subjects will be administered 15mg of Ketorolac. 15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.	Group 3 - 30mg n=80 Participants Subject will receive 30mg of Ketorolac as a part of standard care. 30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control.
Adverse Effect of Dizziness	14 Participants	16 Participants	12 Participants

SECONDARY outcome

Timeframe: 120 minutes

The number of study patients who reported nausea after administration of medication

Outcome measures

Outcome measures
Measure	Group 1 - 10 mg of Ketorolac n=80 Participants Subjects will be administered 10 mg of Ketorolac for pain relief. 10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control.	Group 2 - 15mg n=80 Participants Subjects will be administered 15mg of Ketorolac. 15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.	Group 3 - 30mg n=80 Participants Subject will receive 30mg of Ketorolac as a part of standard care. 30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control.
Adverse Effect of Nausea	9 Participants	11 Participants	8 Participants

SECONDARY outcome

Timeframe: 120 minutes

The number of study patients who reported headache after administration of medication

Outcome measures

Outcome measures
Measure	Group 1 - 10 mg of Ketorolac n=80 Participants Subjects will be administered 10 mg of Ketorolac for pain relief. 10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control.	Group 2 - 15mg n=80 Participants Subjects will be administered 15mg of Ketorolac. 15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.	Group 3 - 30mg n=80 Participants Subject will receive 30mg of Ketorolac as a part of standard care. 30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control.
Adverse Effect of Headache	8 Participants	2 Participants	3 Participants

Adverse Events

Group 1 - 10 mg of Ketorolac

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2 - 15mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 3 - 30mg

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

Dr. Sergey Motov

Maimonides Medical Center

Phone: 718-283-8693

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place