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

Study Overview
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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.

Official Title
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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

Conditions
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Post Tonsillectomy Pain

Intervention / Treatment
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* Drug: 0,1 mg/kg of oxycodone
* Drug: Morphine 0,1 mg/kg
* Drug: Dexamethasone 0,5 mg/kg
* Drug: NaCl 0,9%


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>0,1 mg/kg of oxycodone | Drug: 0,1 mg/kg of oxycodone<br>* solution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia<br>* Other names: Oxynorm;|
| Active Comparator: 2<br>0,1 mg/kg of morphine | Drug: Morphine 0,1 mg/kg<br>* solution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia<br>* Other names: Morphin;|
| Active Comparator: 3<br>0,5 mg/kg dexamethasone (max 24 mg | Drug: Dexamethasone 0,5 mg/kg<br>* solution for injection, 0,5 mg/kg, one injection in the beginning of anesthesia<br>* Other names: Oradexon;|
| Placebo Comparator: 4<br>NaCl 0,9% | Drug: NaCl 0,9%<br>* solution for injection one injection in the beginning of anesthesia<br>* Other names: NaCl 0,9% Braun;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tonsillectomy, paediatric, pain, child, opiates, pre-emptive, oxycodone, morphine, dexamethasone