NCT00643032

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Last Updated

March 25, 2008

Status Verified

March 1, 2008

Enrollment Period

1.8 years

First QC Date

March 19, 2008

Last Update Submit

March 19, 2008

Conditions

Post-Operative PainPre-Operative Anxiety

Study Arms (2)

I

ACTIVE COMPARATOR
Procedure: Transcutaneous iliohypogastric

II

ACTIVE COMPARATOR
Procedure: Perioperative administration near the nerve

Interventions

Transcutaneous iliohypogastricPROCEDURE
I
Perioperative administration near the nervePROCEDURE
II

Eligibility Criteria

Age3 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Known coagulation dysfunction
  • Sensitivity to analgesics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Zvi Steiner, MD

CONTACT

972-4-6304434steiner@hy.health.gov.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 19, 2008

First Posted

March 25, 2008

Study Start

March 1, 2008

Primary Completion

January 1, 2010

Last Updated

March 25, 2008

Record last verified: 2008-03

Locations

IL(1)