Trial Outcomes & Findings for Intranasal Ketorolac for Postsurgical Pain in Dental Implant Patients (NCT NCT01490931)

NCT ID: NCT01490931

Last Updated: 2014-05-09

Results Overview

Pain intensity scores will be recorded by patient employing a standard 100 mm visual analog scale

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 28 participants
• Primary outcome timeframe: 20 minutes post dose
• Results posted on: 2014-05-09

Participant Flow

Consecutive patients in PENN periodontal clinic or faculty practice requiring 1 to 3 dental implants employing lidocaine with epinephrine for anesthesia without significant bone augmentation

Subjects not experiencing moderate pain (at least 40 mm on the pain intensity VAS and moderate or severe pain on the 4-point categorical scale) within 4 hours of surgery were not dosed with ketorolac. Of the 28 enrolled subjects, 25 (89%) achieved at least moderate pain and were dosed.

Participant milestones

Measure	Ketorolac Nasal Spray 31.5 mg (SPRIX) Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intranasal Ketorolac for Postsurgical Pain in Dental Implant Patients

Baseline characteristics by cohort

Measure	Ketorolac Nasal Spray 31.5 mg (SPRIX) n=25 Participants Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants
pain intensity on 100 mm visual analog scale (VAS). 0=No pain 100=worst possible pain	54.4 units on a scale STANDARD_DEVIATION 14.3 • n=5 Participants

PRIMARY outcome

Timeframe: 20 minutes post dose

Pain intensity scores will be recorded by patient employing a standard 100 mm visual analog scale

Outcome measures

Measure	Ketorolac Nasal Spray 31.5 mg (SPRIX) n=25 Participants Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Comparison of Pain Intensity Scores at 20 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period.	14.3 millimeters Standard Error 4.1

PRIMARY outcome

Timeframe: 40 minutes post dose

VAS pain intensity score at 40 minutes post-dose

Outcome measures

Measure	Ketorolac Nasal Spray 31.5 mg (SPRIX) n=25 Participants Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Comparison of Pain Intensity Scores at 40 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period.	10.1 millimeters Standard Error 2.2

PRIMARY outcome

Timeframe: 60 minutes post dose

VAS pain intensity score 60 minutes after dosing.

Outcome measures

Measure	Ketorolac Nasal Spray 31.5 mg (SPRIX) n=25 Participants Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Comparison of Pain Intensity Scores at 60 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period	10.6 millimeters Standard Error 1.8

PRIMARY outcome

Timeframe: 90 minutes post-dose

Outcome measures

Measure	Ketorolac Nasal Spray 31.5 mg (SPRIX) n=25 Participants Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Comparison of Pain Intensity Scores at 90 Minutes With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period	9.6 millimeters Standard Error 2.2

PRIMARY outcome

Timeframe: 2 Hours

Outcome measures

Measure	Ketorolac Nasal Spray 31.5 mg (SPRIX) n=25 Participants Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Comparison of Pain Intensity Scores at 2 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period	9.1 millimeters Standard Error 2.0

PRIMARY outcome

Timeframe: 3 hours post-dose

Outcome measures

Measure	Ketorolac Nasal Spray 31.5 mg (SPRIX) n=25 Participants Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Comparison of Pain Intensity Scores at 3 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period	9.6 millimeters Standard Error 2.2

PRIMARY outcome

Timeframe: 4 Hours post-dose

Outcome measures

Measure	Ketorolac Nasal Spray 31.5 mg (SPRIX) n=25 Participants Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Comparison of Pain Intensity Scores at 4 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period	10.0 millimeters Standard Error 2.0

PRIMARY outcome

Timeframe: 5 Hours post-dose

Outcome measures

Measure	Ketorolac Nasal Spray 31.5 mg (SPRIX) n=25 Participants Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Comparison of Pain Intensity Scores at 5 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period	16.2 millimeters Standard Error 4.3

PRIMARY outcome

Timeframe: 6 Hours post-dose

Outcome measures

Measure	Ketorolac Nasal Spray 31.5 mg (SPRIX) n=25 Participants Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Comparison of Pain Intensity Scores at 6 Hours With the Baseline Pain Intensity Score During the Initial 6-hour Evaluation Period	19.8 millimeters Standard Error 3.7

SECONDARY outcome

Timeframe: Censored at 6 hours

Data will be obtained employing the well-described double stop watch technique

Outcome measures

Measure	Ketorolac Nasal Spray 31.5 mg (SPRIX) n=25 Participants Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
The Median Onset of First Perceptible Pain Relief of Intranasal Ketorolac in Dental Implant Surgery Patients	86 seconds Interval 64.0 to 172.0

SECONDARY outcome

Timeframe: Up to 5 hours after last suture is placed

Population: All subjects (regardless of pain intensity) receiving one to three dental implants

Outcome measures

Measure	Ketorolac Nasal Spray 31.5 mg (SPRIX) n=28 Participants Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Percentage of Subjects Who Reach a Level of at Least Moderate Pain by Achieving a Score of at Least 40 mm on a 100 mm Visual Analog Scale Within 5 Hours After the Completion of Surgery.	89 percentage of participants

SECONDARY outcome

Timeframe: Up to 5 days

Self explanatory

Outcome measures

Measure	Ketorolac Nasal Spray 31.5 mg (SPRIX) n=25 Participants Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Most Frequent Number of Days of Analgesic Dosing in Dental Implant Surgery Patients When Employing Intranasal Ketorolac as Their Pain Medication.	3 days

SECONDARY outcome

Timeframe: At time of depressing meaningful relief stopwatch up to 6 hours.

Measure obtained using recognized double-stop watch technique. Patient is asked to depress the second stop watch when pain relief is meaningful to them. Each patient decides what meaningful relief is for them.

Outcome measures

Measure	Ketorolac Nasal Spray 31.5 mg (SPRIX) n=25 Participants Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Median Onset of Meaningful Pain Relief	172 seconds Interval 132.0 to 735.0

Adverse Events

Ketorolac Nasal Spray 31.5 mg (SPRIX)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ketorolac Nasal Spray 31.5 mg (SPRIX) n=25 participants at risk Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain. Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours
Respiratory, thoracic and mediastinal disorders Nasal burning or stinging	36.0% 9/25 • Number of events 9 • 5 days
Respiratory, thoracic and mediastinal disorders Throat burning	12.0% 3/25 • Number of events 3 • 5 days
Nervous system disorders Headache	12.0% 3/25 • Number of events 3 • 5 days
Respiratory, thoracic and mediastinal disorders Sneezing	8.0% 2/25 • Number of events 2 • 5 days
Gastrointestinal disorders Constipation	4.0% 1/25 • Number of events 1 • 5 days
Respiratory, thoracic and mediastinal disorders Difficulty breathing sensation	4.0% 1/25 • Number of events 1 • 5 days
Ear and labyrinth disorders Ears popping sensation	4.0% 1/25 • Number of events 1 • 5 days
Skin and subcutaneous tissue disorders Perspiring	4.0% 1/25 • Number of events 1 • 5 days
Respiratory, thoracic and mediastinal disorders Runny nose	4.0% 1/25 • Number of events 1 • 5 days
Eye disorders Watery eyes	4.0% 1/25 • Number of events 1 • 5 days

Additional Information

Elliot V Hersh DMD, MS, PhD Professor of Pharmacology

Univeristy of Pennsylvania School of Dental Medicine

Phone: 215-898-9686

Email: evhersh@pobox.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place