The Use of Intranasal Ketoralac for Pain Management
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|ClinicalTrials.gov Identifier: NCT01736358|
Recruitment Status : Terminated (Interim analysis showed futility of primary endpoint)
First Posted : November 29, 2012
Last Update Posted : March 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain Management Urolithiasis||Drug: Intranasal Ketoralac Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, 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|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
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
- Post-operative opioid requirements [ Time Frame: 3 hours after surgery ]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 ]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 ]To find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|