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

Primary Purpose

Post Tonsillectomy Pain

Status

Unknown status

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

0,1 mg/kg of oxycodone

Morphine 0,1 mg/kg

Dexamethasone 0,5 mg/kg

NaCl 0,9%

About this trial

This is an interventional treatment trial for Post Tonsillectomy Pain focused on measuring tonsillectomy, paediatric, pain, child, opiates, pre-emptive, oxycodone, morphine, dexamethasone

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Turku University hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

0,1 mg/kg of oxycodone

0,1 mg/kg of morphine

0,5 mg/kg dexamethasone (max 24 mg

NaCl 0,9%

Outcomes

Primary Outcome Measures

The difference of needed rescue pain medication post operatively

Secondary Outcome Measures

differences in adverse effects

Full Information

NCT ID

NCT00733083

First Posted

August 8, 2008

Last Updated

August 8, 2008

Sponsor

University of Turku

1. Study Identification

Unique Protocol Identification Number

NCT00733083

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Unknown status

Study Start Date

September 2008 (undefined)

Primary Completion Date

December 2009 (Anticipated)

Study Completion Date

December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University of Turku

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Tonsillectomy Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

0,1 mg/kg of oxycodone

Arm Title

Arm Type

Active Comparator

Arm Description

0,1 mg/kg of morphine

Arm Title

Arm Type

Active Comparator

Arm Description

0,5 mg/kg dexamethasone (max 24 mg

Arm Title

Arm Type

Placebo Comparator

Arm Description

NaCl 0,9%

Intervention Type

Drug

Intervention Name(s)

0,1 mg/kg of oxycodone

Other Intervention Name(s)

Oxynorm

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Morphine 0,1 mg/kg

Other Intervention Name(s)

Morphin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexamethasone 0,5 mg/kg

Other Intervention Name(s)

Oradexon

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

NaCl 0,9%

Other Intervention Name(s)

NaCl 0,9% Braun

Intervention Description

solution for injection one injection in the beginning of anesthesia

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

differences in adverse effects

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mari S Aallos-Ravenna, MD

Phone

+35823130655

mari.aallos-ravenna@tyks.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Tuula Manner, MD

Phone

+35823130962

tuula.manner@tyks.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tuula Manner, MD, PhD

Organizational Affiliation

Turku University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Turku University hospital

City

Turku

Country

Finland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mari S Aallos-Ravenna, MD

Phone

+35823130655

mari.aallos-ravenna@tyks.fi

First Name & Middle Initial & Last Name & Degree

Mari S Aallos-Ravenna, MD

12. IPD Sharing Statement

Learn more about this trial

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

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