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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

Page last updated: August 23, 2015

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