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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01147757
Other study ID # 4-2010-0129
Secondary ID
Status Recruiting
Phase N/A
First received June 17, 2010
Last updated December 5, 2011
Start date June 2010
Est. completion date June 2012

Study information

Verified date December 2011
Source Yonsei University
Contact Jeong-Yeon Hong
Email jenyhongg@hanmail.net
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial Summary

Effect of intraoperative remifentanil infusion rate on postoperative tolerance and analgesic consumption in pediatric laparoscopic ureteroneocystostomy.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 5 Years
Eligibility Inclusion Criteria:

- Pediatric patients (ASA physical status I and II) aged between 1-5 yrs and scheduled elective laparoscopic ureteroneocystostomy

Exclusion Criteria:

- cardiovascular, renal, liver disease or growth retardation

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)


Related Conditions & MeSH terms


Intervention

Drug:
remifentanil
During surgery, 3 different dose of remifentanil or placebo was infused.

Locations

Country Name City State
Korea, Republic of Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary fentanyl consumption for IV-PCA 24 h and 48 h after surgery No
Primary Postoperative pain score during 48 h after surgery No
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