Trial Outcomes & Findings for The Use of Intranasal Ketoralac for Pain Management (Sprix) (NCT NCT01736358)

NCT ID: NCT01736358

Last Updated: 2020-02-13

Results Overview

this study will assess the effect of perioperative usage of single-dose of intranasal ketorolac on post operative opioid requirements within 3 hours after surgery.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: 3 hours after surgery
• Results posted on: 2020-02-13

Participant Flow

Participant milestones

Measure	Intranasal Ketoralac A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril. Intranasal Ketoralac: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery	Placebo A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril. Placebo: 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery
Overall Study STARTED	25	25
Overall Study COMPLETED	20	23
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intranasal Ketoralac n=20 Participants A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril. Intranasal Ketoralac: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery	Placebo n=23 Participants A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril. Placebo: 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=23 Participants	0 Participants n=43 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=20 Participants	23 Participants n=23 Participants	43 Participants n=43 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants	0 Participants n=23 Participants	0 Participants n=43 Participants
Age, Continuous	47 years STANDARD_DEVIATION 12.4 • n=20 Participants	49 years STANDARD_DEVIATION 9.3 • n=23 Participants	48 years STANDARD_DEVIATION 11 • n=43 Participants
Sex: Female, Male Female	10 Participants n=20 Participants	11 Participants n=23 Participants	21 Participants n=43 Participants
Sex: Female, Male Male	10 Participants n=20 Participants	12 Participants n=23 Participants	22 Participants n=43 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	20 participants n=20 Participants	23 participants n=23 Participants	43 participants n=43 Participants

PRIMARY outcome

Timeframe: 3 hours after surgery

this study will assess the effect of perioperative usage of single-dose of intranasal ketorolac on post operative opioid requirements within 3 hours after surgery.

Outcome measures

Measure	Intranasal Ketoralac n=20 Participants A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril. Intranasal Ketoralac: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery	Placebo n=23 Participants A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril. Placebo: 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery
Post-operative Opioid Requirements	27.43 mg Interval 23.87 to 51.3	30 mg Interval 22.05 to 48.0

SECONDARY outcome

Timeframe: 30 minutes after surgery

To evaluate the post operative pain score using the Visual Analog Scale (VAS) 30 minutes after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain.

Outcome measures

Measure	Intranasal Ketoralac n=20 Participants A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril. Intranasal Ketoralac: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery	Placebo n=23 Participants A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril. Placebo: 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery
Post Operative Pain Score	4 score on a scale Interval 0.0 to 6.0	3.5 score on a scale Interval 0.0 to 7.75

SECONDARY outcome

Timeframe: 1 hour after surgery

To evaluate the post operative pain score using the Visual Analog Scale (VAS) 1 hour after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain.

Outcome measures

Measure	Intranasal Ketoralac n=20 Participants A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril. Intranasal Ketoralac: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery	Placebo n=23 Participants A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril. Placebo: 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery
Post Operative Pain Score	3.5 score on a scale Interval 0.0 to 5.7	4.5 score on a scale Interval 2.0 to 6.7

SECONDARY outcome

Timeframe: 2 hours after surgery

To evaluate the post operative pain score using the Visual Analog Scale (VAS) 2 hours after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain.

Outcome measures

Measure	Intranasal Ketoralac n=20 Participants A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril. Intranasal Ketoralac: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery	Placebo n=23 Participants A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril. Placebo: 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery
Post Operative Pain Scale	4 score on a scale Interval 0.0 to 7.7	3 score on a scale Interval 0.0 to 5.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours after procedure

To find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population.

Outcome measures

Measure	Intranasal Ketoralac n=20 Participants A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril. Intranasal Ketoralac: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery	Placebo n=23 Participants A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril. Placebo: 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery
Incidence of Postoperative Side Effects	0 number of events	0 number of events

Adverse Events

Intranasal Ketoralac

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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.David Hoenig

Montefiore Medical Center

Email: dhoenig@montefiore.org

Results disclosure agreements

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