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What is the primary objective of this study?

The aim of this randomized, double-blind study is to compare parenteral pre-emptive oxycodone, morphine and dexamethasone with placebo in the treatment of postoperative pain in paediatric patients 4 to 12 years of age. The investigators hope to find out whether there are any differences in postoperative pain and/or adverse effects among these groups.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Post Tonsillectomy Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:0,1 mg/kg of oxycodonesolution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia

Drug:Morphine 0,1 mg/kgsolution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia

Drug:Dexamethasone 0,5 mg/kgsolution for injection, 0,5 mg/kg, one injection in the beginning of anesthesia

Drug:NaCl 0,9%solution for injection one injection in the beginning of anesthesia

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

10,1 mg/kg of oxycodone

20,1 mg/kg of morphine

30,5 mg/kg dexamethasone (max 24 mg

4NaCl 0,9%

Study Status

Unknown status

Start Date: September 2008

Completed Date: December 2010

Phase: N/A

Type: Interventional

Design:

Primary Outcome: The difference of needed rescue pain medication post operatively

Secondary Outcome: differences in adverse effects

Study sponsors, principal investigator, and references

Principal Investigator: Tuula Manner, MD, PhD

Lead Sponsor: University of Turku

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00733083