Preoperative Anxiety and Postoperative Pain in Children

This study is not yet open for participant recruitment.

Verified by Hillel Yaffe Medical Center, March 2008

First Received: March 19, 2008 No Changes Posted

Sponsored by:	Hillel Yaffe Medical Center
Information provided by:	Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:	NCT00643032

Purpose

We wish to study which method of local injection of analgesic (before or during surgery) is the more effective method to reduce post-operative pain in children. In addition, we wish to study which pre-operative educational intervention is more effective in reducing anxiety in children and their family.

Condition	Intervention	Phase
Post-Operative Pain Pre-Operative Anxiety	Procedure: Transcutaneous iliohypogastric Procedure: Perioperative administration near the nerve	Phase IV

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control, Efficacy Study
Official Title:	Comparison of 2 Methods to Reduce Postoperative Pain in Children and a Comparison of 3 Methods of Preoperative Education Intervention to Reduce Anxiety in Children and Their Family

Further study details as provided by Hillel Yaffe Medical Center:

Estimated Enrollment:	250
Study Start Date:	March 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Active Comparator	Procedure: Transcutaneous iliohypogastric
II: Active Comparator	Procedure: Perioperative administration near the nerve

Eligibility

Ages Eligible for Study:	3 Months to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Healthy
ASA I - II
Undergoing elective day surgery

Exclusion Criteria:

Known coagulation dysfunction
Sensitivity to analgesics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643032

Contacts

Contact: Zvi Steiner, MD

972-4-6304434

steiner@hy.health.gov.il

Locations

Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100

Sponsors and Collaborators

Hillel Yaffe Medical Center

More Information

No publications provided

Responsible Party:	Hillel Yaffe Medical Center ( Dr. Zvi Steiner )
Study ID Numbers:	50/2007
Study First Received:	March 19, 2008
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00643032 History of Changes
Health Authority:	Israel: Ministry of Health

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Signs and Symptoms
Pathologic Processes
Postoperative Complications
Pain
Pain, Postoperative

ClinicalTrials.gov processed this record on May 07, 2009