Post Tonsillectomy Pain | A Comparative Study With Parenteral Oxycodone, Morphine and Dexamethasone in Postoperative Pain in Paediatric Patients
Post Tonsillectomy Pain research study
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
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
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
Start Date: September 2008
Completed Date: December 2010
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