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

NCT00733083 | Unknown

• 1 other identifier: DOM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Tonsillectomy Pain

Keywords

tonsillectomy; paediatric; pain; child; opiates; pre-emptive; oxycodone; morphine; dexamethasone

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• differences in adverse effects

  In hospital 4 hours with first hour in 15 min intervals, then 30 min. At home 24+48h

Study Arms (4)

1

ACTIVE COMPARATOR

0,1 mg/kg of oxycodone

Drug: 0,1 mg/kg of oxycodone

2

ACTIVE COMPARATOR

0,1 mg/kg of morphine

Drug: Morphine 0,1 mg/kg

3

ACTIVE COMPARATOR

0,5 mg/kg dexamethasone (max 24 mg

Drug: Dexamethasone 0,5 mg/kg

4

PLACEBO COMPARATOR

NaCl 0,9%

Drug: NaCl 0,9%

Interventions

0,1 mg/kg of oxycodone DRUG

solution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia

Also known as: Oxynorm

1

Morphine 0,1 mg/kg DRUG

solution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia

Also known as: Morphin

2

Dexamethasone 0,5 mg/kg DRUG

solution for injection, 0,5 mg/kg, one injection in the beginning of anesthesia

Also known as: Oradexon

3

NaCl 0,9% DRUG

solution for injection one injection in the beginning of anesthesia

Also known as: NaCl 0,9% Braun

4

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Allergy to morphine, oxycodone or dexamethasone

Sponsors & Collaborators

• University of Turku: lead

Study Sites (1)

Turku University hospital

Turku, Finland

Location

MeSH Terms

Conditions

Pain

Interventions

Morphine; Dexamethasone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Tuula Manner, MD, PhD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mari S Aallos-Ravenna, MD

CONTACT

+35823130655; mari.aallos-ravenna@tyks.fi

Tuula Manner, MD

CONTACT

+35823130962; tuula.manner@tyks.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2008
• First Posted: August 12, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: August 12, 2008

Record last verified: 2008-08

Locations

FI (1)