Pediatric study to evaluate the appropriate dose for aprepitant in pediatric patients undergoing surgery.
- Conditions
- Post Operative Nausea and Vomiting in surgical patients.MedDRA version: 15.1 Level: LLT Classification code 10036901 Term: Prophylaxis against postoperative nausea and vomiting System Organ Class: 100000004865Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Registration Number
- EUCTR2011-006006-27-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 228
1. Patient is birth (at least 37 weeks gestation and =3 kg of weight) to 17 years of age at the time of randomization.
2. Patient is scheduled to receive general anesthesia AND:
Patients must have at least one of the following risk factors for PONV (in
addition to receiving general anesthesia):
o Surgery with an associated risk of PONV: tonsillectomy, adenoidectomy, strabismus surgery, dental surgery, hydrocelectomy, orchidopexy or herniorraphy –ORo Operative procedure associated with PONV: intraoperative use or anticipated opioid administration within the first 24 following surgery.
Are the trial subjects under 18? yes
Number of subjects for this age range: 260
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
1. Patient is undergoing emergency surgery for a life threatening condition.
2. Patient is scheduled to receive propofol for maintenance of
anesthesia. (Note: propofol is permitted for induction of anesthesia).
3. Patient is expected to receive opioid antagonists (e.g., naloxone,
naltrexone) or benzodiazepine antagonists (e.g., flumazenil)
4. Patient is scheduled to undergo cardiac or neurosurgery.
5. Patient has vomited within 24 hours prior to surgery.
6. Patient has an active infection (e.g., pneumonia), any uncontrolled
disease (e.g., diabetic ketoacidosis, pre-existing gastrointestinal
conditions/gastrointestinal obstruction) except for malignancy, or a
history of any illness, which, in the opinion of the investigator, might
confound the results of the study or pose unwarranted risk in
administering study drug/comparator to the patient.
7. Patient has a nasogastric or oral gastric tube intra- or postoperatively
for suctioning gastric contents (Note: nasogastric or oral
gastric tube intra- or post-operatively may ONLY be used for feeding.
Patients should be excluded if a nasogastric or oral gastric tube is
routinely used for the type of surgery to be performed).
8. Patients with a know history of CT prolongation.
9. Patient is allergic to aprepitant, ondansetron or any 5-HT3 antagonist.
10. Patient is taking the anti-coagulant warfarin.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: To estimate post-operative aprepitant plasma concentration profiles and<br> pharmacokinetic parameters by population analysis including historical data (e.g. Cmax, Tmax, AUC0-8, t1/2, CL/F) in Dose 1, 2, 3 (Dose 4 if needed) obtained from pediatric patients from birth to 17 years of age administered oral aprepitant preoperatively.<br> Safety:<br> To evaluate the safety and tolerability of the administered dose(s) of aprepitant in pediatric patients from birth to 17 years of age.<br> ;Secondary Objective: No secondary objective.;<br> Primary end point(s): Pharmacokinetic endpoints are Cmax, Tmax, AUC0-8, t1/2 and CL/F<br> estimated by population methods, including the use of historic data in<br> the population modeling, in each age group for all aprepitant treatments.<br> ;Timepoint(s) of evaluation of this end point: -30
- Secondary Outcome Measures
Name Time Method Secondary end point(s): There are no secondary end points for this study.;Timepoint(s) of evaluation of this end point: There are no secondary end points for this study.