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

• ClinicalTrials.gov Identifier: NCT02078492
• Recruitment Status: Completed
• First Posted: March 5, 2014
• Results First Posted: April 10, 2017
• Last Update Posted: April 10, 2017
• Sponsor: Antonios Likourezos
• Information provided by (Responsible Party): Antonios Likourezos, Maimonides Medical Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pain
• Interventions: Drug: 10 mg of Ketorolac; Drug: 15 mg of Ketorolac; Drug: 30 mg of Ketorolac
• Enrollment: 240

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Group 1 - 10 mg of Ketorolac	Group 2 - 15mg	Group 3 - 30mg
Arm/Group Description	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.	Subjects will be administered 15mg of Ketorolac. 15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.	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.
Period Title: Overall Study
Started	80	80	80
Completed	80	80	80
Not Completed	0	0	0

Baseline Characteristics

Arm/Group Title		Group 1 - 10 mg of Ketorolac	Group 2 - 15mg	Group 3 - 30mg	Total
Arm/Group Description		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.	Subjects will be administered 15mg of Ketorolac. 15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.	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 of all reporting groups
Overall Number of Baseline Participants		80	80	80	240
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	80 participants	80 participants	80 participants	240 participants
		41.5 (12.1)	40.1 (12.1)	38.8 (11.6)	40.2 (11.9)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	80 participants	80 participants	80 participants	240 participants
	Female	41 51.2%	48 60.0%	43 53.8%	132 55.0%
	Male	39 48.8%	32 40.0%	37 46.3%	108 45.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	80 participants	80 participants	80 participants	240 participants
		80	80	80	240

Outcome Measures

1. Primary Outcome

Title	Pain Score at 30 Minutes
Description	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.
Time Frame	30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1 - 10 mg of Ketorolac	Group 2 - 15mg	Group 3 - 30mg
Arm/Group Description:	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.	Subjects will be administered 15mg of Ketorolac. 15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.	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 Number of Participants Analyzed	80	80	80
Mean (Standard Deviation); Unit of Measure: pain score
	5.14 (2.70)	5.05 (2.56)	4.81 (2.85)

2. Secondary Outcome

Title	Adverse Effect of Dizziness
Description	the number of study patients who reported having dizziness after administration of medication.
Time Frame	120 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1 - 10 mg of Ketorolac	Group 2 - 15mg	Group 3 - 30mg
Arm/Group Description:	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.	Subjects will be administered 15mg of Ketorolac. 15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.	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 Number of Participants Analyzed	80	80	80
Measure Type: Count of Participants; Unit of Measure: Participants
	14 17.5%	16 20.0%	12 15.0%

3. Secondary Outcome

Title	Adverse Effect of Nausea
Description	The number of study patients who reported nausea after administration of medication
Time Frame	120 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1 - 10 mg of Ketorolac	Group 2 - 15mg	Group 3 - 30mg
Arm/Group Description:	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.	Subjects will be administered 15mg of Ketorolac. 15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.	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 Number of Participants Analyzed	80	80	80
Measure Type: Count of Participants; Unit of Measure: Participants
	9 11.3%	11 13.8%	8 10.0%

4. Secondary Outcome

Title	Adverse Effect of Headache
Description	The number of study patients who reported headache after administration of medication
Time Frame	120 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1 - 10 mg of Ketorolac	Group 2 - 15mg	Group 3 - 30mg
Arm/Group Description:	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.	Subjects will be administered 15mg of Ketorolac. 15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.	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 Number of Participants Analyzed	80	80	80
Measure Type: Count of Participants; Unit of Measure: Participants
	8 10.0%	2 2.5%	3 3.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1 - 10 mg of Ketorolac, Group 2 - 15mg, Group 3 - 30mg
	Comments	The main hypothesis was that there would be equivalence of dose effect across the three groups at every time point, and the primary comparison consisted of the pain assessment at 30 minutes.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	We assumed a minimal clinically significant difference (MCSD) of 1.3 between the three ketorolac groups at the 30-minute pain assessment and a standard deviation of 3.0. A power analysis determined that a sample of 78 subjects per group provided at least 80% power to detect an MCSD of at least 1.3 at 30 minutes with α=0.05.
Statistical Test of Hypothesis	P-Value	.783
	Comments	[Not Specified]
	Method	ANOVA
	Comments	2 degrees of freedom

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Group 1 - 10 mg of Ketorolac	Group 2 - 15mg	Group 3 - 30mg
Arm/Group Description	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.	Subjects will be administered 15mg of Ketorolac. 15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control.	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.
All-Cause Mortality
	Group 1 - 10 mg of Ketorolac	Group 2 - 15mg	Group 3 - 30mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	Group 1 - 10 mg of Ketorolac	Group 2 - 15mg	Group 3 - 30mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/80 (0.00%)	0/80 (0.00%)	0/80 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Group 1 - 10 mg of Ketorolac	Group 2 - 15mg	Group 3 - 30mg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/80 (0.00%)	0/80 (0.00%)	0/80 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Sergey Motov
• Organization: Maimonides Medical Center
• Phone: 718-283-8693
• EMail: smotov@maimonidesmed.org

Publications:

Catapano MS. The analgesic efficacy of ketorolac for acute pain. J Emerg Med. 1996 Jan-Feb;14(1):67-75. Review.

• Responsible Party: Antonios Likourezos, Maimonides Medical Center
• ClinicalTrials.gov Identifier: NCT02078492
• Other Study ID Numbers: 2014-01-19
• First Submitted: March 3, 2014
• First Posted: March 5, 2014
• Results First Submitted: January 3, 2017
• Results First Posted: April 10, 2017
• Last Update Posted: April 10, 2017