Celecoxib (Celebrex) in the Management of Acute Renal Colic

The study will be conducted as a prospective, randomized, double-blind controlled clinical
trial. One-hundred and fifty-four patients with symptoms of acute renal colic and a ureteral
calculus less than 10 mm in largest diameter on flat plain abdominal x-ray (KUB) or
non-contrast computer tomography (CT) scan will be randomized in this trial. At the time of
presentation with acute renal colic to the Emergency Department, the patient will be
recruited for involvement. After informed consent, patients will be provided either 200 mg
of Celebrex or a placebo equivalent. They will be instructed to follow the recommended
dosing regimen for acute pain, taking two tablets in the emergency room (400 mg), followed
by one tablet 12 hours later (200 mg), then one tablet twice a day for 10 days. Patients
will be provided a prescription for Vicodin (1-2 tablets of 5/500 every 4-6 hours) to be
taken as required for pain. Throughout the study, patients will be asked to strain urine for
passage of calculus and note date and time of passage. Patients will also be asked to
maintain a daily narcotic diary and complete a daily pain analog scale provided by our
institution. Patients will be followed in the Urology Department's Stone Clinic with weekly
imaging studies (KUB or CT scan) and renal function tests (serum creatinine) for 4 weeks.

Inclusion Criteria:

- Ureteral calculus <= 10 mm in largest diameter

- Patient elects conservative management over immediate surgical intervention

Exclusion Criteria:

- Solitary kidney

- Renal insufficiency (creatinine [CR] > 1.8)

- Urinary infection (fever > 101 degrees Fahrenheit, positive urine culture, many
bacteria on urinalysis)

- Allergic-type reactions to sulfonamides

- Patients with known hypersensitivity to celecoxib

- Patients who have experienced asthma, urticaria, or allergic-type reactions after
taking aspirin or nonsteroidal anti-inflammatory agents (NSAIDs)

- Prior history of gastrointestinal (GI) bleed or active gastric ulcer disease

- Pregnancy/nursing

- Moderate-severe hepatic dysfunction (Child-Pugh Classification B or C)

- Concomitant use of drugs that inhibit P450 2C9, drugs metabolized by P450 2D6, ACE
inhibitors, furosemide, warfarin (and other anticoagulants, not including low-dose
aspirin), fluconazole, or lithium

- Women of child-bearing age unwilling to use effective contraception for the duration
of the trial.

- Significant or unstable cardiovascular disease defined as:

- myocardial infarction or stroke less than 3 months prior to the study
randomization

- planned revascularization (percutaneous coronary intervention [PCI] or coronary
artery bypass surgery [CABG]) at the time of study screening

- angina at rest or uncontrolled angina

- hospitalization or emergency department visits for cardiac-related illness less
than 3 months prior to randomization

- uncontrolled hypertension (defined as systolic blood pressure [BP] > 140 mmHg
and/or diastolic BP > 90 mmHg at the baseline visit)

- evidence of cardiac electrophysiologic instability including history of
uncontrolled complex ventricular arrhythmia, uncontrolled atrial fibrillation or
flutter, or uncontrolled supraventricular tachycardias with a ventricular
response heart rate of > 100 beats per minute (BPM) at rest. (Subjects whose
cardiac electrophysiologic instability is controlled with a pacemaker or
implantable cardioverter defibrillator (ICD) are eligible.)

- symptoms, signs or treatment for congestive heart failure (CHF) or known left
ventricular dysfunction with ejection fraction < 40%

- undergone coronary bypass surgery or any major surgery (cardiac or noncardiac)
or trauma within the past 3 months