A Comparative Study With Parenteral Oxycodone, Morphine and Dexamethasone in Postoperative Pain in Paediatric Patients

Post Tonsillectomy Pain Clinical Trial

— DOM  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00733083
• Other study ID #: DOM
• Status: Not yet recruiting
• Phase: N/A
• First received: August 8, 2008
• Last updated: August 8, 2008
• Start date: September 2008
• Est. completion date: December 2010

Study information

• Verified date: August 2008
• Source: University of Turku
• Contact: Mari S Aallos-Ravenna, MD
• Phone: +35823130655
• Email: mari.aallos-ravenna[@]tyks.fi
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Tonsillectomy Pain

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Finland	Turku University hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference of needed rescue pain medication post operatively		predetermined intervals being 15 min during the first postoperative hour, followed by interval of 30 min for 4 first postop hours. At home pain and adverse effects are registered by parent at 24 hours and 48 hours.	No
Secondary	differences in adverse effects		In hospital 4 hours with first hour in 15 min intervals, then 30 min. At home 24+48h	Yes