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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00733083
Date of registration: 08/08/2008
Primary sponsor: University of Turku
Public title: A Comparative Study With Parenteral Oxycodone, Morphine and Dexamethasone in Postoperative Pain in Paediatric Patients DOM
Scientific title: A Comparative Study With Pre-Emptive Parenteral Oxycodone, Morphine and Dexamethasone in the Treatment of Postoperative Pain in Paediatric Patients 4 to 12 Years of Age
Date of first enrolment: September 2008
Target sample size: 100
Recruitment status: Not yet recruiting
URL:  http://clinicaltrials.gov/show/NCT00733083
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment  
Countries of recruitment
Finland
Contacts
Name:   Mari S Aallos-Ravenna, MD
Address: 
Telephone: +35823130655
Email: mari.aallos-ravenna@tyks.fi
Affiliation: 
Name:   Mari S Aallos-Ravenna, MD
Address: 
Telephone: +35823130655
Email: mari.aallos-ravenna@tyks.fi
Affiliation: 
Name:   Tuula Manner, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Turku University Hospital
Key inclusion & exclusion criteria

Inclusion Criteria:

- 4 to 12 years of age

- Scheduled to tonsillectomy

- ASA class I or II

- Written informed consent is obtained from the parents and the child (when
appropriate).

Exclusion Criteria:

- Allergy to morphine, oxycodone or dexamethasone



Age minimum: 4 Years
Age maximum: 12 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Post Tonsillectomy Pain
Intervention(s)
Drug: 0,1 mg/kg of oxycodone
Drug: Dexamethasone 0,5 mg/kg
Drug: Morphine 0,1 mg/kg
Drug: NaCl 0,9%
Primary Outcome(s)
The difference of needed rescue pain medication post operatively [Time Frame: predetermined intervals being 15 min during the first postoperative hour, followed by interval of 30 min for 4 first postop hours. At home pain and adverse effects are registered by parent at 24 hours and 48 hours.]
Secondary Outcome(s)
differences in adverse effects [Time Frame: In hospital 4 hours with first hour in 15 min intervals, then 30 min. At home 24+48h]
Secondary ID(s)
DOM
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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