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Preoperative Anxiety and Postoperative Pain in Children

Primary Purpose

Post-Operative Pain, Pre-Operative Anxiety

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Transcutaneous iliohypogastric
Perioperative administration near the nerve
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Operative Pain

Eligibility Criteria

3 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Healthy
  • ASA I - II
  • Undergoing elective day surgery

Exclusion Criteria:

  • Known coagulation dysfunction
  • Sensitivity to analgesics

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

I

II

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 19, 2008
Last Updated
March 19, 2008
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00643032
Brief Title
Preoperative Anxiety and Postoperative Pain in Children
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Pain, Pre-Operative Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Active Comparator
Arm Title
II
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous iliohypogastric
Intervention Type
Procedure
Intervention Name(s)
Perioperative administration near the nerve

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy ASA I - II Undergoing elective day surgery Exclusion Criteria: Known coagulation dysfunction Sensitivity to analgesics
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zvi Steiner, MD
Phone
972-4-6304434
Email
steiner@hy.health.gov.il
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reuma Barkan
Email
reuma@hy.health.gov.il

12. IPD Sharing Statement

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Preoperative Anxiety and Postoperative Pain in Children

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