Trial Outcomes & Findings for Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine (IN) for Postoperative Pain (NCT NCT01351090)
NCT ID: NCT01351090
Last Updated: 2012-10-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
127 participants
Primary outcome timeframe
8-hour intervals from the start of dosing through 24 hours
Results posted on
2012-10-18
Participant Flow
Recruitment period - October 2001 through August 2002 Locations - Hospitals
Subjects must have been requesting pain medication and have at lease moderate pain defined as a score of at least 40 mm on a 100-mm VAS.
Participant milestones
| Measure |
Ketorolac IN 10 mg
10 mg Intranasal (2 x 100 uL of a 5% solution)
|
Ketorolac IN 30 mg
30 mg Intranasal (2 x 100 uL of a 15% solution)
|
Placebo Vehicle IN
Intranasal placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
42
|
42
|
|
Overall Study
COMPLETED
|
32
|
31
|
36
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine (IN) for Postoperative Pain
Baseline characteristics by cohort
| Measure |
Ketorolac IN 10 mg
n=43 Participants
10 mg Intranasal (2 x 100 uL of a 5% solution)
|
Ketorolac IN 30 mg
n=42 Participants
30 mg Intranasal (2 x 100 uL of a 15% solution)
|
Placebo Vehicle IN
n=42 Participants
Intranasal placebo
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Age Continuous
|
49.7 years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
56.7 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 1.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Region of Enrollment
New Zealand
|
43 participants
n=5 Participants
|
42 participants
n=7 Participants
|
42 participants
n=5 Participants
|
127 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8-hour intervals from the start of dosing through 24 hoursOutcome measures
| Measure |
Ketorolac IN 10 mg
n=41 Participants
10 mg Intranasal (2 x 100 uL of a 5% solution)
|
Ketorolac IN 30 mg
n=41 Participants
30 mg Intranasal (2 x 100 uL of a 15% solution)
|
Placebo Vehicle IN
n=41 Participants
Intranasal placebo
|
|---|---|---|---|
|
Total Morphine Sulfate (MS) Use in Milligrams by Patient-controlled Analgesia (PCA) Through 24 Hours
|
54.32 mg
Standard Deviation 6.36
|
37.77 mg
Standard Deviation 4.98
|
56.45 mg
Standard Deviation 4.82
|
SECONDARY outcome
Timeframe: 8-hour intervals from the start of dosing through 48 hoursOutcome measures
| Measure |
Ketorolac IN 10 mg
n=38 Participants
10 mg Intranasal (2 x 100 uL of a 5% solution)
|
Ketorolac IN 30 mg
n=35 Participants
30 mg Intranasal (2 x 100 uL of a 15% solution)
|
Placebo Vehicle IN
n=39 Participants
Intranasal placebo
|
|---|---|---|---|
|
Total MS Use in Milligrams by PCA From the Start of Dosing Through 48 Hours
|
78.66 mg
Standard Deviation 11.20
|
61.39 mg
Standard Deviation 10.79
|
87.87 mg
Standard Deviation 9.36
|
SECONDARY outcome
Timeframe: 8-hour intervals from 24 hours after the start of dosing through 48 hoursOutcome measures
| Measure |
Ketorolac IN 10 mg
n=38 Participants
10 mg Intranasal (2 x 100 uL of a 5% solution)
|
Ketorolac IN 30 mg
n=35 Participants
30 mg Intranasal (2 x 100 uL of a 15% solution)
|
Placebo Vehicle IN
n=39 Participants
Intranasal placebo
|
|---|---|---|---|
|
Total MS Use in Milligrams by PCA From 24 Hours After the Start of Dosing Through 48 Hours
|
28.25 mg
Standard Deviation 5.67
|
23.11 mg
Standard Deviation 5.31
|
32.61 mg
Standard Deviation 4.77
|
SECONDARY outcome
Timeframe: 6 hours after study drug administrationRatings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. PID was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication.
Outcome measures
| Measure |
Ketorolac IN 10 mg
n=43 Participants
10 mg Intranasal (2 x 100 uL of a 5% solution)
|
Ketorolac IN 30 mg
n=42 Participants
30 mg Intranasal (2 x 100 uL of a 15% solution)
|
Placebo Vehicle IN
n=42 Participants
Intranasal placebo
|
|---|---|---|---|
|
Pain Intensity Difference (PID) Scores
|
34.1 units on a scale
Standard Deviation 2.7
|
38.9 units on a scale
Standard Deviation 2.1
|
29.1 units on a scale
Standard Deviation 2.3
|
Adverse Events
Ketorolac IN 10 mg
Serious events: 3 serious events
Other events: 43 other events
Deaths: 0 deaths
Ketorolac IN 30 mg
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
Placebo Vehicle IN
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ketorolac IN 10 mg
n=43 participants at risk
10 mg Intranasal (2 x 100 uL of a 5% solution)
|
Ketorolac IN 30 mg
n=42 participants at risk
30 mg Intranasal (2 x 100 uL of a 15% solution)
|
Placebo Vehicle IN
n=42 participants at risk
Intranasal placebo
|
|---|---|---|---|
|
Cardiac disorders
Pulmonary embolism
|
2.3%
1/43 • Number of events 1 • 8 months
|
4.8%
2/42 • Number of events 2 • 8 months
|
0.00%
0/42 • 8 months
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.3%
1/43 • Number of events 1 • 8 months
|
0.00%
0/42 • 8 months
|
0.00%
0/42 • 8 months
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/43 • 8 months
|
2.4%
1/42 • Number of events 1 • 8 months
|
0.00%
0/42 • 8 months
|
|
Gastrointestinal disorders
Hematemesis
|
2.3%
1/43 • Number of events 1 • 8 months
|
0.00%
0/42 • 8 months
|
0.00%
0/42 • 8 months
|
|
Vascular disorders
Thrombus in popliteal vein
|
0.00%
0/43 • 8 months
|
0.00%
0/42 • 8 months
|
2.4%
1/42 • Number of events 1 • 8 months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/43 • 8 months
|
2.4%
1/42 • Number of events 1 • 8 months
|
0.00%
0/42 • 8 months
|
|
Investigations
Allergic reaction
|
0.00%
0/43 • 8 months
|
2.4%
1/42 • Number of events 1 • 8 months
|
0.00%
0/42 • 8 months
|
Other adverse events
| Measure |
Ketorolac IN 10 mg
n=43 participants at risk
10 mg Intranasal (2 x 100 uL of a 5% solution)
|
Ketorolac IN 30 mg
n=42 participants at risk
30 mg Intranasal (2 x 100 uL of a 15% solution)
|
Placebo Vehicle IN
n=42 participants at risk
Intranasal placebo
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.0%
3/43 • 8 months
|
2.4%
1/42 • 8 months
|
0.00%
0/42 • 8 months
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
18.6%
8/43 • 8 months
|
9.5%
4/42 • 8 months
|
23.8%
10/42 • 8 months
|
|
Vascular disorders
Hypotension NOS
|
9.3%
4/43 • 8 months
|
7.1%
3/42 • 8 months
|
14.3%
6/42 • 8 months
|
|
Blood and lymphatic system disorders
Anemia NOS
|
27.9%
12/43 • 8 months
|
26.2%
11/42 • 8 months
|
33.3%
14/42 • 8 months
|
|
Cardiac disorders
Tachycardia NOS
|
16.3%
7/43 • 8 months
|
19.0%
8/42 • 8 months
|
40.5%
17/42 • 8 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/43 • 8 months
|
7.1%
3/42 • 8 months
|
7.1%
3/42 • 8 months
|
|
Gastrointestinal disorders
Constipation
|
18.6%
8/43 • 8 months
|
26.2%
11/42 • 8 months
|
23.8%
10/42 • 8 months
|
|
Gastrointestinal disorders
Dyspesia
|
7.0%
3/43 • 8 months
|
2.4%
1/42 • 8 months
|
0.00%
0/42 • 8 months
|
|
Gastrointestinal disorders
Flatulence
|
4.7%
2/43 • 8 months
|
7.1%
3/42 • 8 months
|
4.8%
2/42 • 8 months
|
|
Gastrointestinal disorders
Nausea
|
58.1%
25/43 • 8 months
|
45.2%
19/42 • 8 months
|
47.6%
20/42 • 8 months
|
|
Gastrointestinal disorders
Vomiting NOS
|
27.9%
12/43 • 8 months
|
28.6%
12/42 • 8 months
|
26.2%
11/42 • 8 months
|
|
General disorders
Pyrexia
|
55.8%
24/43 • 8 months
|
33.3%
14/42 • 8 months
|
61.9%
26/42 • 8 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.6%
5/43 • 8 months
|
7.1%
3/42 • 8 months
|
2.4%
1/42 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.0%
3/43 • 8 months
|
4.8%
2/42 • 8 months
|
9.5%
4/42 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Peripheral swelling
|
4.7%
2/43 • 8 months
|
2.4%
1/42 • 8 months
|
9.5%
4/42 • 8 months
|
|
Nervous system disorders
Dizziness
|
16.3%
7/43 • 8 months
|
14.3%
6/42 • 8 months
|
11.9%
5/42 • 8 months
|
|
Nervous system disorders
Headache
|
34.9%
15/43 • 8 months
|
21.4%
9/42 • 8 months
|
21.4%
9/42 • 8 months
|
|
Nervous system disorders
Somnolence
|
20.9%
9/43 • 8 months
|
2.4%
1/42 • 8 months
|
11.9%
5/42 • 8 months
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
1/43 • 8 months
|
7.1%
3/42 • 8 months
|
4.8%
2/42 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
1/43 • 8 months
|
7.1%
3/42 • 8 months
|
2.4%
1/42 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/43 • 8 months
|
4.8%
2/42 • 8 months
|
7.1%
3/42 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.3%
4/43 • 8 months
|
11.9%
5/42 • 8 months
|
4.8%
2/42 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal passage irritation
|
14.0%
6/43 • 8 months
|
16.7%
7/42 • 8 months
|
11.9%
5/42 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
7.0%
3/43 • 8 months
|
0.00%
0/42 • 8 months
|
4.8%
2/42 • 8 months
|
Additional Information
David Bregamn, M.D., Ph.D.
Luitpold Pharmaceuticals, Inc.
Phone: 610-650-4200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place