Post Tonsillectomy PainDOMNCT00733083
A Comparative Study With Parenteral Oxycodone, Morphine and Dexamethasone in Postoperative Pain in Paediatric Patients
A study testing 0,1 mg/kg of oxycodone, Morphine 0,1 mg/kg and Dexamethasone 0,5 mg/kg in people with Post Tonsillectomy Pain, run by University of Turku at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Post Tonsillectomy Pain
- What is being tested?
- 0,1 mg/kg of oxycodone, Morphine 0,1 mg/kg and Dexamethasone 0,5 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- Allergy to morphine, oxycodone or dexamethasone
Trial locations and contacts
1 site in 1 country.
Finland1 site
Turku University hospital
Turku
Mari S Aallos-Ravenna, MD, +35823130655, mari.aallos-ravenna@tyks.fi
Mari S Aallos-Ravenna, MD
About this study
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 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.
Read the 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.
- Conditions
- Post Tonsillectomy Pain
- Being tested
- 0,1 mg/kg of oxycodone, Morphine 0,1 mg/kg, Dexamethasone 0,5 mg/kg, NaCl 0,9%
- Keywords
- tonsillectomy, paediatric, pain, child, opiates, pre-emptive, oxycodone, morphine, dexamethasone
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0,1 mg/kg of oxycodoneDrug
Also called Oxynorm
solution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia
Morphine 0,1 mg/kgDrug
Also called Morphin
solution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia
Dexamethasone 0,5 mg/kgDrug
Also called Oradexon
solution for injection, 0,5 mg/kg, one injection in the beginning of anesthesia
NaCl 0,9%Drug
Also called NaCl 0,9% Braun
solution for injection one injection in the beginning of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 0,1 mg/kg of oxycodone Receives: Drug: 0,1 mg/kg of oxycodone |
| 2 | Active comparator | 0,1 mg/kg of morphine Receives: Drug: Morphine 0,1 mg/kg |
| 3 | Active comparator | 0,5 mg/kg dexamethasone (max 24 mg Receives: Drug: Dexamethasone 0,5 mg/kg |
| 4 | Placebo comparator | NaCl 0,9% Receives: Drug: NaCl 0,9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of needed rescue pain medication post operatively
Measured: 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 outcomes (1)
differences in adverse effects
Measured: In hospital 4 hours with first hour in 15 min intervals, then 30 min. At home 24+48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Tonsillectomy PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Investigators
- Tuula Manner, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733083
- Sponsor's protocol ID
- DOM
- Acronym
- DOM
- Status last verified
- Aug 2008
- First submitted
- 8 Aug 2008
- Last updated
- 12 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00733083
- Acronym / sponsor ID
- DOM / DOM
- Conditions
- Post Tonsillectomy Pain
- Keywords
- tonsillectomy, paediatric, pain, child, opiates, pre-emptive, oxycodone, morphine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 12 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: 0,1 mg/kg of oxycodone0,1 mg/kg of oxycodone |
| 2 | Active comparator | Drug: Morphine 0,1 mg/kg0,1 mg/kg of morphine |
| 3 | Active comparator | Drug: Dexamethasone 0,5 mg/kg0,5 mg/kg dexamethasone (max 24 mg |
| 4 | Placebo comparator | Drug: NaCl 0,9%NaCl 0,9% |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Allergy to morphine, oxycodone or dexamethasone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0,1 mg/kg of oxycodoneAlso: Oxynormsolution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia | Drug | 1 |
| Morphine 0,1 mg/kgAlso: Morphinsolution for injection, 0,1 mg/kg, one injection in the beginning of anesthesia | Drug | 2 |
| Dexamethasone 0,5 mg/kgAlso: Oradexonsolution for injection, 0,5 mg/kg, one injection in the beginning of anesthesia | Drug | 3 |
| NaCl 0,9%Also: NaCl 0,9% Braunsolution for injection one injection in the beginning of anesthesia | Drug | 4 |
Primary outcome
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.
1 secondary outcome
differences in adverse effects
Time frame: In hospital 4 hours with first hour in 15 min intervals, then 30 min. At home 24+48h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuula Manner, MD, PhD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0,1 mg/kg of oxycodone, Morphine 0,1 mg/kg and Dexamethasone 0,5 mg/kg in people with Post Tonsillectomy Pain, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mari S Aallos-Ravenna, MD (+35823130655, mari.aallos-ravenna@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2008.