A Comparative Study With Parenteral Oxycodone, Morphine and Dexamethasone in Postoperative Pain in Paediatric Patients (DOM)
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Post Tonsillectomy Pain |
Drug: 0,1 mg/kg of oxycodone Drug: Morphine 0,1 mg/kg Drug: Dexamethasone 0,5 mg/kg Drug: NaCl 0,9% |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
- 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. ] [ Designated as safety issue: No ]
- differences in adverse effects [ Time Frame: In hospital 4 hours with first hour in 15 min intervals, then 30 min. At home 24+48h ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: 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 Name: Oradexon
|
|
Placebo Comparator: 4
NaCl 0,9%
|
Drug: NaCl 0,9%
solution for injection one injection in the beginning of anesthesia
Other Name: NaCl 0,9% Braun
|
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.
Eligibility| Ages Eligible for Study: | 4 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Mari S Aallos-Ravenna, MD | +35823130655 | mari.aallos-ravenna@tyks.fi |
| Contact: Tuula Manner, MD | +35823130962 | tuula.manner@tyks.fi |
| Finland | |
| Turku University hospital | Not yet recruiting |
| Turku, Finland | |
| Contact: Mari S Aallos-Ravenna, MD +35823130655 mari.aallos-ravenna@tyks.fi | |
| Principal Investigator: Mari S Aallos-Ravenna, MD | |
| Principal Investigator: | Tuula Manner, MD, PhD | Turku University Hospital |
More Information
No publications provided
| Responsible Party: | MD, PhD Tuula Manner, Turku university hospital, Finland |
| ClinicalTrials.gov Identifier: | NCT00733083 History of Changes |
| Other Study ID Numbers: | DOM |
| Study First Received: | August 8, 2008 |
| Last Updated: | August 8, 2008 |
| Health Authority: | Finland: Finnish Medicines Agency |
Keywords provided by University of Turku:
|
tonsillectomy paediatric pain child opiates |
pre-emptive oxycodone morphine dexamethasone |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Morphine Oxycodone BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Analgesics, Opioid Analgesics |
ClinicalTrials.gov processed this record on May 19, 2013