A Study to Evaluate the Safety and Efficacy of Ultiva (Remifentanil Hydrochloride) in Pediatric Participants General Anesthetised

PHASE3CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
Anesthesia
Interventions
DRUG

Remifentanil

After intubation, continuous intravenous infusion of remifentanil (0.25 µg/kg/min) is started, while anesthesia is maintained with inhaled or intravenous anesthetics. In cases where sedation by general anesthetics and analgesia by lidocaine does not seem to provide a sufficient means of analgesia at the time of intubation, remifentanil may be used, beginning before intubation. The rate of infusion may be adjusted while monitoring the subject's general condition in 25% to 100% increments or in 25% to 50% decrements every 2 to 5 minutes, but should not exceed 1.3 µg/kg/min.

Trial Locations (9)

Unknown

Asahikawa

Kobe

Kure

Kurume

Ohmura

Osaka

Shimajiri

Shimotsuke

Tokyo

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY

NCT01998165 - A Study to Evaluate the Safety and Efficacy of Ultiva (Remifentanil Hydrochloride) in Pediatric Participants General Anesthetised | Biotech Hunter | Biotech Hunter