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

August 8, 2008 updated by: University of Turku

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
0,1 mg/kg of oxycodone
Drug: 0,1 mg/kg of oxycodone
solution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia
Other Names:
  • Oxynorm
ACTIVE_COMPARATOR: 2
0,1 mg/kg of morphine
Drug: Morphine 0,1 mg/kg
solution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia
Other Names:
  • Morphin
ACTIVE_COMPARATOR: 3
0,5 mg/kg dexamethasone (max 24 mg
Drug: Dexamethasone 0,5 mg/kg
solution for injection, 0,5 mg/kg, one injection in the beginning of anesthesia
Other Names:
  • Oradexon
PLACEBO_COMPARATOR: 4
NaCl 0,9%
Drug: NaCl 0,9%
solution for injection one injection in the beginning of anesthesia
Other Names:
  • NaCl 0,9% Braun

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The difference of needed rescue pain medication post operatively
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Time Frame
differences in adverse effects
Time Frame: In hospital 4 hours with first hour in 15 min intervals, then 30 min. At home 24+48h
In hospital 4 hours with first hour in 15 min intervals, then 30 min. At home 24+48h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Investigators

  • Principal Investigator: Tuula Manner, MD, PhD, Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ANTICIPATED)

December 1, 2009

Study Completion (ANTICIPATED)

December 1, 2010

Study Registration Dates

First Submitted

August 8, 2008

First Submitted That Met QC Criteria

August 8, 2008

First Posted (ESTIMATE)

August 12, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 12, 2008

Last Update Submitted That Met QC Criteria

August 8, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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