Brief Summary
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.
Brief Title
The Use of Intranasal Ketoralac for Pain Management (Sprix)
Detailed Description
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Postoperative Pain Management
Urolithiasis
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
Sprix
Intranasal ketoralac
Ketoralac
Urolithiasis
Kidney stone
Uretal stone
Ureteroscopic removal of stones
URS
Pain management
Pain
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
65 Years
Minimum Age
18 Years
NCT Id
NCT01736358
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
12-02-244
Overall Status
Terminated
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Evaluating Post-operative Pain Management Efficacy of Intra Nasal Ketorolac in Ambulatory Urological Surgeries-A Randomized Double-blinded Placebo Controlled Study
Primary Outcomes
Outcome Description
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 Measure
Post-operative Opioid Requirements
Outcome Time Frame
3 hours after surgery
Secondary Outcomes
Outcome Description
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 Time Frame
30 minutes after surgery
Outcome Measure
Post Operative Pain Score
Outcome Description
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 Time Frame
1 hour after surgery
Outcome Measure
Post Operative Pain Score
Outcome Description
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 Time Frame
2 hours after surgery
Outcome Measure
Post Operative Pain Scale
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
65
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Joshua Stern
Investigator Email
jstern@montefiore.org
Investigator Phone
718-920-4531