A Comparative Study With Parenteral Oxycodone, Morphine and Dexamethasone in Postoperative Pain in Paediatric Patients
NCT ID: NCT00733083
Last Updated: 2008-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2008-09-30
2010-12-31
Brief Summary
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Detailed Description
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The patients are followed minimum 4h postoperatively: first in the recovery room, and after the patient is stable enough the study is continued in the day-patient unit. Level of pain and adverse effects are registered all on same predetermined intervals being 15 min during the first postoperative hour, followed by interval of 30 min until the discharge.
The safety measurements noted include pulse, respiratory rate, non-invasive blood pressure and peripheral oxygen saturation are recorded on the same intervals The registering of pain, adverse effects and given medication continues at home for 48 hours post operatively with a questionnaire filled by the parents.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
0,1 mg/kg of oxycodone
0,1 mg/kg of oxycodone
solution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia
2
0,1 mg/kg of morphine
Morphine 0,1 mg/kg
solution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia
3
0,5 mg/kg dexamethasone (max 24 mg
Dexamethasone 0,5 mg/kg
solution for injection, 0,5 mg/kg, one injection in the beginning of anesthesia
4
NaCl 0,9%
NaCl 0,9%
solution for injection one injection in the beginning of anesthesia
Interventions
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0,1 mg/kg of oxycodone
solution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia
Morphine 0,1 mg/kg
solution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia
Dexamethasone 0,5 mg/kg
solution for injection, 0,5 mg/kg, one injection in the beginning of anesthesia
NaCl 0,9%
solution for injection one injection in the beginning of anesthesia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled to tonsillectomy
* ASA class I or II
* Written informed consent is obtained from the parents and the child (when appropriate).
Exclusion Criteria
4 Years
12 Years
ALL
No
Sponsors
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University of Turku
OTHER
Responsible Party
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Turku university hospital, Finland
Principal Investigators
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Tuula Manner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Turku University Hospital
Locations
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Turku University hospital
Turku, , Finland
Countries
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Central Contacts
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Facility Contacts
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Mari S Aallos-Ravenna, MD
Role: primary
Other Identifiers
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DOM
Identifier Type: -
Identifier Source: org_study_id