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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00733083 |
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Date of registration:
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08/08/2008 |
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Primary sponsor: |
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Public title:
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A Comparative Study With Parenteral Oxycodone, Morphine and Dexamethasone in Postoperative Pain in Paediatric Patients
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Scientific title:
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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 |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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100 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00733083 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Finland
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Contacts
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Name:
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Mari S Aallos-Ravenna, MD |
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Address:
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Telephone:
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+35823130655 |
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Email:
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mari.aallos-ravenna@tyks.fi |
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Affiliation:
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Name:
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Mari S Aallos-Ravenna, MD |
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Address:
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Telephone:
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+35823130655 |
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Email:
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mari.aallos-ravenna@tyks.fi |
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Affiliation:
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Name:
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Tuula Manner, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Turku University Hospital |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Post Tonsillectomy Pain
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Intervention(s)
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Drug: 0,1 mg/kg of oxycodone
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Drug: Dexamethasone 0,5 mg/kg
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Drug: Morphine 0,1 mg/kg
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Drug: NaCl 0,9%
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Primary Outcome(s)
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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.]
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Secondary Outcome(s)
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differences in adverse effects
[Time Frame: In hospital 4 hours with first hour in 15 min intervals, then 30 min. At home 24+48h]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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