The Use of Intranasal Ketoralac for Pain Management
Recruitment status was: Recruiting
Postoperative Pain Management
Drug: Intranasal Ketoralac
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Evaluating Post-operative Pain Management Efficacy of Intra Nasal Ketorolac in Ambulatory Urological Surgeries-A Randomized Double-blinded Placebo Controlled Study|
- Post-operative opioid requirements [ Time Frame: 3 hours after surgery ] [ Designated as safety issue: No ]To evaluate the role perioperative usage of single-dose of intranasal ketorolac on immediate post operative opioid requirements.
- Post operative pain score [ Time Frame: 3 hours after surgery ] [ Designated as safety issue: No ]To evaluate the post operative pain score 30 minutes after surgery, 1 hour after surgery, and 2 hours after surgery.
- Incidence of postoperative side effects [ Time Frame: 24 hours after procedure ] [ Designated as safety issue: Yes ]To find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population.
|Study Start Date:||October 2012|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: 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.
Drug: Intranasal Ketoralac
15.75 mg of Sprix in each nostril 20 minutes before end of surgery
Other Name: Sprix
Placebo Comparator: 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.
15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery
The prevalence and incidence of urolithiasis, or kidney stone disease, are increasing in the general population. Life-time incidence of urolithiasis is estimated to be between 5%- 12%. The treatment of kidney stones depends on stone type and size, symptom severity, and the presence of obstruction.
URS is a common ambulatory procedure as improved technological advances and increased clinical utilization have helped decrease postoperative complications. Despite an overall reduction in the perioperative complication rate, post operative pain management after URS remains a major factor delaying discharge of patients.
Post operative pain after URS is usually treated with opioids and non steroidal anti inflammatory drugs. Intranasal ketorolac (SprixTM) is an FDA approved pain formulation for short term management (5 days) of moderate to moderately severe pain that requires analgesia at the opioid level. The efficacy of intranasal ketorolac formulation was demonstrated in placebo-controlled studies in patients following major surgeries.
The primary objective of the study is to evaluate the role perioperative usage of single-dose of intranasal ketorolac on immediate post operative opioid requirements. Secondary objectives of the study are to (a) evaluate the post operative pain score 30 minutes after surgery, 1 hour after surgery, and 2 hours after surgery, (b) find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population, (c) find the level of anesthesia satisfaction in the target population, (d) find the time to discharge in the target population, (e) compare the two groups post anesthesia discharge score.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736358
|United States, New York|
|Montefiore Medical Center- Weiler Division|
|Bronx, New York, United States, 10461|
|Principal Investigator:||David Hoenig, MD||Montefiore Medical Center|
|Study Director:||Singh Nair, MD||Montefiore Medical Center|