Clinical trial NCT01736358: The Use of Intranasal Ketoralac for Pain Management (Sprix)
Official title: Evaluating Post-operative Pain Management Efficacy of Intra Nasal Ketorolac in Ambulatory Urological Surgeries-A Randomized Double-blinded Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Postoperative Pain Management
Urolithiasis
Keywords: Sprix
Intranasal ketoralac
Ketoralac
Urolithiasis
Kidney stone
Uretal stone
Ureteroscopic removal of stones
URS
Pain management
Pain
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Post-operative Opioid Requirements
timeFrame: 3 hours after surgery
Secondary outcomes:
measure: Post Operative Pain Score
timeFrame: 30 minutes after surgery
measure: Post Operative Pain Score
timeFrame: 1 hour after surgery
measure: Post Operative Pain Scale
timeFrame: 2 hours after surgery
Other outcomes:
measure: Incidence of Postoperative Side Effects
timeFrame: 24 hours after procedure
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center- Weiler Division
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Singh Nair, MD
role: STUDY_DIRECTOR
References:
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