The Use of Intranasal Ketoralac for Pain Management (Sprix)

Study Overview
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Brief Summary
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Despite an overall reduction in the perioperative complication rate, post operative pain management after ureteroscopic removal of stones (URS) remains a major factor delaying discharge of patients. The investigators hypothesize that perioperative usage of intranasal ketorolac will provide a reduction in post operative opioid requirements, better post operative pain control, higher anesthesia satisfaction and faster recovery.

Detailed Description
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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.

Official Title
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Evaluating Post-operative Pain Management Efficacy of Intra Nasal Ketorolac in Ambulatory Urological Surgeries-A Randomized Double-blinded Placebo Controlled Study

Conditions
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Postoperative Pain Management, Urolithiasis

Intervention / Treatment
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* Drug: Intranasal Ketoralac
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ureteroscopic stone removal surgeries with stenting Age ≥ 18 years and < 65 years Stable patient with stable vital signs Mentally competent and is able to understand consent form Exclusion Criteria: Unstable patients Patients with multiple trauma sites Patients with allergies to ketorolac or any of the components in the nasal spray preparation Patients with active peptic ulcer disease History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs Renal disease or at risk for renal failure due to volume depletion Pregnant or nursing mothers Nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor) Any other contraindication to the use of Sprix, or in whom use of Sprix would not be consistent with the approved package insert

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Ketoralac<br>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<br>* 15.75 mg of Sprix in each nostril 20 minutes before end of surgery<br>* Other names: Sprix;|
| Placebo Comparator: Placebo<br>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. | Drug: Placebo<br>* 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Opioid Requirements | 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. | 3 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Pain Score | 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. | 30 minutes after surgery | 
| Post Operative Pain Score | 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. | 1 hour after surgery | 
| Post Operative Pain Scale | 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. | 2 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sprix, Intranasal ketoralac, Ketoralac, Urolithiasis, Kidney stone, Uretal stone, Ureteroscopic removal of stones, URS, Pain management, Pain