Clinical trial NCT01998165: A Study to Evaluate the Safety and Efficacy of Ultiva (Remifentanil Hydrochloride) in Pediatric Participants General Anesthetised
Official title: An Open-Label Study to Evaluate the Efficacy and Safety of JNJ-268229 in Pediatric Subjects General Anesthetised
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Keywords: Anesthesia
Remifentanil
Ultiva
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2013-11-28
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of JNJ-268229 (Ultiva /Remifentanil Hydrochloride) in pediatric participants between 1 and 15 years of age during maintenance of general anesthesia.

Detailed description: This is multicenter, open-label (identity of assigned study drug will be known) one-arm study in pediatric participants receiving general anesthesia. The participants are children aged 1-15 years old, planned to undergo head and neck, thoracic (except heart), urological, orthopedic or plastic surgery. Approximately 80 participants will be enrolled in this study. These participants are divided into two groups by age (1-6 and 7-15 years old). Pharmacokinetic (what the body does to the drug,) blood samples will be collected from at least 3 participants between the ages of 1 and 6 years and at least 3 participants between the ages of 7 and 15 years from 15 minutes after the start of infusion to the end of infusion of the study drug . The study consists of 4 phases: screening phase, treatment phase, recovery phase and follow-up phase. Screening for eligible participants will be performed within 14 days before administration of the study drug. The safety and tolerability of study drug will be evaluated by physical examinations, electrocardiogram (ECG), clinical laboratory tests, vital signs, and adverse events (AEs) according to the Time and Events Schedule. Participants safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Participants scheduled to receive surgery under general anesthesia, necessitating airway securing with tracheal intubation and analgesia with opioid analgesics
* American Society of Anesthesiologists (ASA) Physical Status Classification is I or II at the time of operation planning
* Participants scheduled to receive operations estimated to take 30 minutes or more from skin incision i.e. Head and neck, thoracic (except heart), intraperitoneal, ophthalmological, otorhinolaryngological, urological, orthopedic or plastic surgery
* Girls having undergone menarche are eligible only if the urine pregnancy test at the time of screening is negative Exclusion Criteria:-
* Chronic use of opioid analgesics or their use within 12 hours before the planned start of general anesthesia - Hypersensitivity to opioid analgesics or local anesthetics
* History of jaundice or unexplained fever induced by halogenated anesthetics
* Unstable hemodynamics (eg. congenital heart disease, congenital diaphragmatic hernia) Ideal body weight is not within the 10th to 90th percentile received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the planned first dose of study drug or is currently enrolled in an investigational study

Primary outcomes:
measure: Number of participants with positive response to skin incision
timeFrame: 5-minute assessment period after skin incision
Secondary outcomes:
measure: Hemodynamics stability
timeFrame: 5-60 minutes before the start of intubation, 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure
measure: Drugs used to deal with insufficient anesthesia (inadequate anesthesia) or excessive anesthesia
timeFrame: Time interval between completion of anesthesia and extubation
measure: Assessment on analgesic effect
timeFrame: 240 minutes after completion of anesthesia
measure: Total dose level of remifentanil
timeFrame: 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure
measure: Total concomitant anesthetic dose level
timeFrame: 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure
measure: Time from completion of anesthesia to resumption of spontaneous respiration
timeFrame: 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure
measure: Time until arrival of Steward Postanesthetic Recovery Score at 6
timeFrame: 240 minutes after completion of anesthesia or skin closure
measure: Time from completion of anesthesia to discharge from the recovery room
timeFrame: 240 minutes after completion of anesthesia or skin closure
measure: Respiratory stability
timeFrame: 5-60 minutes before the start of intubation, 1-5 minutes before the planned start of the first skin incision. and 240 minutes after completion of anesthesia or skin closure
Other outcomes:
Locations:
city: Asahikawa
country: Japan
city: Kobe
country: Japan
city: Kure
country: Japan
city: Kurume
country: Japan
city: Ohmura
country: Japan
city: Osaka
country: Japan
city: Shimajiri
country: Japan
city: Shimotsuke
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: