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Trial record 56 of 463 for:    KETOROLAC

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

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 - 10 mg of Ketorolac Group 2 - 15mg Group 3 - 30mg
Hide 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
Arm/Group Title Group 1 - 10 mg of Ketorolac Group 2 - 15mg Group 3 - 30mg Total
Hide 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
Hide 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
1.Primary Outcome
Title Pain Score at 30 Minutes
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 - 10 mg of Ketorolac Group 2 - 15mg Group 3 - 30mg
Hide 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
Hide Description the number of study patients who reported having dizziness after administration of medication.
Time Frame 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 - 10 mg of Ketorolac Group 2 - 15mg Group 3 - 30mg
Hide 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
Hide Description The number of study patients who reported nausea after administration of medication
Time Frame 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 - 10 mg of Ketorolac Group 2 - 15mg Group 3 - 30mg
Hide 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
Hide Description The number of study patients who reported headache after administration of medication
Time Frame 120 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 - 10 mg of Ketorolac Group 2 - 15mg Group 3 - 30mg
Hide 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%
Show Statistical Analysis 1 Hide 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
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
Hide 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   --/--   --/--   --/-- 
Show Serious Adverse Events Hide 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%) 
Show Other (Not Including Serious) Adverse Events Hide 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%) 
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
Responsible Party: Antonios Likourezos, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT02078492     History of Changes
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