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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University of Turku.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Turku
ClinicalTrials.gov Identifier:
NCT00733083
First received: August 8, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by University of Turku:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733083

Contacts
Contact: Mari S Aallos-Ravenna, MD +35823130655 mari.aallos-ravenna@tyks.fi
Contact: Tuula Manner, MD +35823130962 tuula.manner@tyks.fi

Locations
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         
Sponsors and Collaborators
University of Turku
Investigators
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
Narcotics

ClinicalTrials.gov processed this record on September 18, 2014