post open surgery pain (incuding but not limited to orthopedic, abdominal, thoracic, plastic/reconstructive, neurologic [spine], or urologic procedures) MedDRA version: 18.0 Level: PT Classification code 10033371 Term: Pain System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Interventions
Trade Name: SPRIX® (ketorolac tromethamine) Nasal Spray
Pharmaceutical Form: Nasal spray
INN or Proposed INN: KETOROLAC TROMETAMOL
CAS Number: 74103-07-4
Concentration unit: % (W/W) percent weight/wei
Sponsors
Luitpold Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patient age 0-11 years. 2. Undergoing an open surgical procedure expected to result in at least moderate pain based on an age appropriate pain scale. 3. Body mass index (BMI) = 95th percentile for age. 4. Surgical procedures that would allow the subject to likely remain in hospital until the morning of post-operative day 3 (to complete PK sample collection). 5. Newborns and infants able to complete the study procedures and pain scales with parental/guardian assistance and cooperative children, willing and able to complete the study procedures, pain scales and to communicate meaningfully with study personnel. 6. In generally good health and capable of undergoing surgery. 7. Females at risk of pregnancy were to use an acceptable form of birth control and have a negative serum or urine pregnancy test (although it is anticipated that all 0-11-year old subjects will be pre-menarchal). 8. Wilingness of the subjects parents or guardian to refrain from use of non-study analgesics for the duration of the study, from the day of surgery up to post-operative day 4 9. Subject’s parent or guardian willingness and ability to sign the informed consent (ICF) approved by the IRB. Cooperative children’s (= 6 years old) willingness to take part in the study - relevant versions of ICF tailored to the age group have been prepared and can be signed by the subject optionally. Are the trial subjects under 18? yes Number of subjects for this age range: 48 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Surgical procedure performed exclusively by laparoscopy. 2. Known allergy (asthma, urticaria or any other allergic reaction) or sensitivity to ketorolac, acetylsalicylic acid, ethylene diamine tetraacetic acid (EDTA), or any nonsteroidal anti-inflammatory drug (NSAID). 3. Prior nasal-septal injury or surgery. 4. History of peptic ulcer, gastro-esophageal reflux, or gastrointestinal bleeding. 5. History of advanced renal impairment or a risk for renal failure due to volume depletion. 6. Clinically significant (in the Investigator’s opinion) laboratory test value outside the normal range. 7. The patient requires regular use (daily use in at least 25 days per month) in the 3 months prior to surgery of NSAIDs, COX2 inhibitors, tramadol, or acetaminophen at daily dose of more than 2 g for the management of pain. 8. Contraindication to the use of morphine, general anesthetics, bupivacaine, ropivacaine, lidocaine, other local anesthetics, muscle relaxants, hydrocodone, ondansetron, or acetaminophen (eg, significant history of allergic reactions or intolerance to these or related substances). 9. Known bleeding diathesis or other disorder or current use of agents affecting coagulation. Deep venous thrombosis prophylaxis of the surgeon’s choice is permitted postoperatively. 10. Current use of CNS active drugs such as benzodiazepines, tricyclic antidepressants, or SSRIs for pain. These drugs are permitted for non-pain indications if the dose has been stable for at least 30 days. The use of lorazepam and other sleep medications, except those containing analgesic properties, are permitted. 11. Current diabetes mellitus and HbA1C > 9.5 or a history of prolonged uncontrolled diabetes. 12. Use of an antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days. 13. Any medical condition that in the investigator’s opinion could adversely impact the patient’s participation or safety, conduct of the study, or interfere with the pain assessments, including active infection. 14 History of drug, prescription medicine, or alcohol abuse that would interfere with the subject’s safety or the assessments of efficacy in this trial, in the judgment of the investigator. 15. History of nasal mucosal damage or active seasonal allergies, nasal congestion or upper respiratory tract infection sufficient to interfere with intranasal drug delivery. 16. Administration of an investigational product within 3 months prior to the first dose of study drug, or scheduled to receive an investigational product, while participating in the study. 17. Use of Toradol (ketorolac tromethamine) in any formulation within the apst 30 days prior to study entry and throughout study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the pharmacokinetics and safety of postoperative administration of SPRIX® in pediatric patients (ages 0-11) undergoing open surgical procedures.;Secondary Objective: To assess the efficacy of postoperative administration of SPRIX® in pediatric patients (ages 0-11) undergoing open surgical procedures.;Primary end point(s): Safety and pharmacokinetics;Timepoint(s) of evaluation of this end point: Safety: clinical and laboratory procedures, with the addition of continuous pulse oximetry for the measurement of oxygen saturation during the period of parenteral opioid use and nasal examinations to evaluate local toxicity. Pharmacokinetics: blood samples will be collected at 0.25, 0.5, 0.75, 1,2,4,6 hours (prior to subsequent dose of study drug) after drug administration until the morning of Day 2. Then blood samples will be collected at 1,2,4,6,8,12 and 24 hours after receiving study drug. If the patient decides to continue treatment, blood sample will be collected 24 hours post dose on the morning of post-operative Day 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy;Timepoint(s) of evaluation of this end point: At pre-dose as well as 30 and 60 minutes, and 2, 4, 6, 8, 12, 18, 24, 30, 36, 42, and 48 hours after the first dose then following the 48-hour dose, immediately before each subsequent dose up to 5 days in total, a pain intensity assessments will be conducted utilizing the age appropriate scale (FLACC or FACES) | — |
Countries
Poland
Contacts
Public ContactClinical Trial Information
Luitpold Pharmaceuticals, Inc.
Outcome results
None listed