The Use of Intranasal Ketoralac for Pain Management (Sprix)

Phase 4

Terminated

Conditions: Postoperative Pain Management
Urolithiasis

Interventions: Drug: Intranasal Ketoralac
Drug: Placebo

Registration Number: NCT01736358

Lead Sponsor: Montefiore Medical Center

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal Ketoralac	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Post-operative Opioid Requirements	3 hours after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Post Operative Pain Scale	2 hours after surgery	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.
Post Operative Pain Score	1 hour after surgery	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.