A Comparative Study With Parenteral Oxycodone, Morphine and Dexamethasone in Postoperative Pain in Paediatric Patients
Information source: University of Turku
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Tonsillectomy Pain
Intervention: 0,1 mg/kg of oxycodone (Drug); Morphine 0,1 mg/kg (Drug); Dexamethasone 0,5 mg/kg (Drug); NaCl 0,9% (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: University of Turku Official(s) and/or principal investigator(s): Tuula Manner, MD, PhD, Principal Investigator, Affiliation: Turku University Hospital
Overall contact: Mari S Aallos-Ravenna, MD, Phone: +35823130655, Email: mari.aallos-ravenna@tyks.fi
Summary
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.
Clinical Details
Official 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: The difference of needed rescue pain medication post operatively
Secondary outcome: differences in adverse effects
Detailed description:
After the induction of anaesthesia and before intubation the child receives one of the
research drugs in a double-blind fashion: 0. 1 mg/kg of oxycodone , 0. 1 mg/kg of morphine,
0. 5 mg/kg dexamethasone (max 24 mg), or placebo. All the research drugs are diluted into a
dose of 10 ml with NaCl 0. 9%, the placebo being solely the dilute.
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.
Eligibility
Minimum age: 4 Years.
Maximum age: 12 Years.
Gender(s): Both.
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
Locations and Contacts
Mari S Aallos-Ravenna, MD, Phone: +35823130655, Email: mari.aallos-ravenna@tyks.fi
Turku University hospital, Turku, Finland; Not yet recruiting Mari S Aallos-Ravenna, MD, Phone: +35823130655, Email: mari.aallos-ravenna@tyks.fi Mari S Aallos-Ravenna, MD, Principal Investigator
Additional Information
Starting date: September 2008
Last updated: August 8, 2008
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