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

NCT ID: NCT00733083

Last Updated: 2008-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Post Tonsillectomy Pain

Keywords

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tonsillectomy paediatric pain child opiates pre-emptive oxycodone morphine dexamethasone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

0,1 mg/kg of oxycodone

Group Type ACTIVE_COMPARATOR

0,1 mg/kg of oxycodone

Intervention Type DRUG

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

2

0,1 mg/kg of morphine

Group Type ACTIVE_COMPARATOR

Morphine 0,1 mg/kg

Intervention Type DRUG

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

3

0,5 mg/kg dexamethasone (max 24 mg

Group Type ACTIVE_COMPARATOR

Dexamethasone 0,5 mg/kg

Intervention Type DRUG

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

4

NaCl 0,9%

Group Type PLACEBO_COMPARATOR

NaCl 0,9%

Intervention Type DRUG

solution for injection one injection in the beginning of anesthesia

Interventions

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0,1 mg/kg of oxycodone

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

Intervention Type DRUG

Morphine 0,1 mg/kg

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

Intervention Type DRUG

Dexamethasone 0,5 mg/kg

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

Intervention Type DRUG

NaCl 0,9%

solution for injection one injection in the beginning of anesthesia

Intervention Type DRUG

Other Intervention Names

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Oxynorm Morphin Oradexon NaCl 0,9% Braun

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Turku university hospital, Finland

Principal Investigators

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Tuula Manner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

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Turku University hospital

Turku, , Finland

Site Status

Countries

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Finland

Central Contacts

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Mari S Aallos-Ravenna, MD

Role: CONTACT

Phone: +35823130655

Email: [email protected]

Tuula Manner, MD

Role: CONTACT

Phone: +35823130962

Email: [email protected]

Facility Contacts

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Mari S Aallos-Ravenna, MD

Role: primary

Other Identifiers

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DOM

Identifier Type: -

Identifier Source: org_study_id