NCT01041378

Brief Summary

The purpose of this study is to evaluate postoperative pain control for pediatric patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable pain

Status
completed

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

First Submitted

Initial submission to the registry

December 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 16, 2010

Status Verified

May 1, 2010

Enrollment Period

4 months

First QC Date

December 30, 2009

Last Update Submit

June 15, 2010

Conditions

Keywords

Pediatric patients (6 months-5 years) scheduled elective day-case orchiopexy

Outcome Measures

Primary Outcomes (1)

  • Children's Hospital of Eastern Ontario Pain Scale, CHEOPS and Faces, Legs, Activity, Cry, and Consolability, FLACC

    postoperative 24 hours

Interventions

Intravenous dexamethasone (0.5mg/kg) before incision

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pediatric patients scheduled for elective day-case orchiopexy.

You may not qualify if:

  • Infants or children with history of steroid allergy, renal, hepatic disease, or contraindication for caudal analgesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hong JY, Han SW, Kim WO, Kim EJ, Kil HK. Effect of dexamethasone in combination with caudal analgesia on postoperative pain control in day-case paediatric orchiopexy. Br J Anaesth. 2010 Oct;105(4):506-10. doi: 10.1093/bja/aeq187. Epub 2010 Jul 20.

MeSH Terms

Conditions

Pain

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 30, 2009

First Posted

December 31, 2009

Study Start

January 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 16, 2010

Record last verified: 2010-05