The Use of Intranasal Ketoralac for Pain Management

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.

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