Postoperative PainPhase 1/2propanNCT01342835
Postoperative Analgesia in Children After Propofol Anesthesia
A Phase 1/2 study testing Propofol in people with Postoperative Pain, run by University Clinical Centre of Kosova at 1 site in Serbia.
Trial summary
The investigators hypothesize that patients anesthetized with sevoflurane have more pain, postoperatively, than those anesthetized with propofol. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSerbia
- Study dates
- Sep 2010to Jul 2011
- Phase
- Phase 1/2
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient is 3- 6 years old
- Patient is scheduled for hernia repair surgery at University Clinical center of Kosovo Patients is ASA I/II Patient meets criteria to receive either propofol or sevoflurane anesthesia Patient's parent/guardian provides written consent
Who cannot join
- allergy to any of the drugs
- preoperative anxiety
- postoperative agitation
- ASA physical status >II
Trial locations and contacts
1 site in 1 country.
Antiogna Hasani contact
Serbia1 site, 1 recruiting
- Recruiting
University Clinical Center of Kosovo
Pristina, Kosovo, 10000
Antigona Hasani, MD,MSC, +38138500600 ext. 3015, antigona.hasani@gmail.com
About this study
The investigators hypothesize that patients anesthetized with sevoflurane have more pain, postoperatively, than those anesthetized with propofol.
Read the detailed description
In a randomize, prospective, double-blind study, the subjects are 100 premedicated children, aged 3 to 6 years, who undergo one type of surgical procedure, hernia repair surgery. Anesthesia is maintains with propofol anesthesia (group P, n=50) or with sevoflurane anesthesia (group S, n=50). and fentanyl administered during surgery. Faces Pain Scale (FPS) is use to assess pain severity.
- Conditions
- Postoperative Pain
- Being tested
- Propofol
- Keywords
- propofol, sevoflurane, postoperative pain, children
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan, Sevorane
The induction dose of propofol is 3-5 mg/kg-1 (mean induction dose: 4 mg/kg-1) follow by propofol infusion (12 mg/kg/h-1 for the first 10 min of general anesthesia, 9 mg/kg/h-1 for another 10 min, and 6 mg/kg/h-1 thereafter; mean maintenance dose: 9 mg/kg/h-1) and a 50:50 mixture of N2O and O2.
| Study group | Role | What they receive |
|---|---|---|
| drug: propofol | Active comparator | Drug:Propofol and sevoflurane The induction dose of propofol is 3-5 mg/kg-1 (mean induction dose: 4 mg/kg-1) follow by propofol infusion (12 mg/kg/h-1 for the first 10 min of general anesthesia, 9 mg/kg/h-1 for another 10 min, and 6 mg/kg/h-1 thereafter; mean maintenance dose: 9 mg/kg/h-1) and a 50:50 mixture of N2O and O2. Receives: Drug: Propofol |
| Sevoflurane group:sevoflurane | Active comparator | Drug:Sevoflurane and Propofol Mask induction is perform with sevoflurane (4-6%) follow by 1.5-2% sevoflurane in a 50:50 mixture of N2O and O2. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
The Faces Pain Scale (FPS) (from five face drawings: 0 = no pain, 5 = extreme pain) is used to assess pain severity
Measured: 120 minutes
Secondary outcomes (2)
recovery time
Recovery time, defined as the time until eye opening on command or the time of first response to command after anesthesia
Measured: 120 minutes
adverse effects
Adverse effects during the surgery and after recovery: hypotension, bradicardia, intense coughing, hypersalivation and laryngospasm, nausea, and vomiting.
Measured: 0-120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startSep 2010
- Primary completionJan 2011
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Clinical Centre of Kosova
- Sponsor type
- University, hospital or other
- Investigators
- Antigona Hasani, MD,MSC, Principal investigator, University Clinical Centre of Kosova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342835
- Sponsor's protocol ID
- UCCK-55
- Other IDs
- RAA12
- Acronym
- propan
- Status last verified
- Sep 2010
- First submitted
- 20 Apr 2011
- Last updated
- 27 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia in Children After Propofol Anesthesia
- ClinicalTrials.gov ID
- NCT01342835
- Acronym / sponsor ID
- propan / UCCK-55
- Conditions
- Postoperative Pain
- Keywords
- propofol, sevoflurane, postoperative pain, children
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Clinical Centre of KosovaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2011 (estimated)
- First posted
- 27 Apr 2011 (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 investigators hypothesize that patients anesthetized with sevoflurane have more pain, postoperatively, than those anesthetized with propofol.
Detailed description
In a randomize, prospective, double-blind study, the subjects are 100 premedicated children, aged 3 to 6 years, who undergo one type of surgical procedure, hernia repair surgery. Anesthesia is maintains with propofol anesthesia (group P, n=50) or with sevoflurane anesthesia (group S, n=50). and fentanyl administered during surgery. Faces Pain Scale (FPS) is use to assess pain severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug: propofol | Active comparator | Drug: PropofolDrug:Propofol and sevoflurane The induction dose of propofol is 3-5 mg/kg-1 (mean induction dose: 4 mg/kg-1) follow by propofol infusion (12 mg/kg/h-1 for the first 10 min of general anesthesia, 9 mg/kg/h-1 for another 10 min, and 6 mg/kg/h-1 thereafter; mean maintenance dose: 9 mg/kg/h-1) and a 50:50 mixture of N2O and O2. |
| Sevoflurane group:sevoflurane | Active comparator | Drug: PropofolDrug:Sevoflurane and Propofol Mask induction is perform with sevoflurane (4-6%) follow by 1.5-2% sevoflurane in a 50:50 mixture of N2O and O2. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patient is 3- 6 years old
- Patient is scheduled for hernia repair surgery at University Clinical center of Kosovo Patients is ASA I/II Patient meets criteria to receive either propofol or sevoflurane anesthesia Patient's parent/guardian provides written consent
Key exclusion criteria (4 listed)
- allergy to any of the drugs
- preoperative anxiety
- postoperative agitation
- ASA physical status >II
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 |
|---|---|---|
| PropofolAlso: Diprivan, SevoraneThe induction dose of propofol is 3-5 mg/kg-1 (mean induction dose: 4 mg/kg-1) follow by propofol infusion (12 mg/kg/h-1 for the first 10 min of general anesthesia, 9 mg/kg/h-1 for another 10 min, and 6 mg/kg/h-1 thereafter; mean maintenance dose: 9 mg/kg/h-1) and a 50:50 mixture of N2O and O2. | Drug | Sevoflurane group:sevoflurane, drug: propofol |
Primary outcome
postoperative pain
Time frame: 120 minutes
The Faces Pain Scale (FPS) (from five face drawings: 0 = no pain, 5 = extreme pain) is used to assess pain severity
2 secondary outcomes
recovery time
Time frame: 120 minutes
adverse effects
Time frame: 0-120 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2011.
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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.
Antiogna Hasani contact
Antigona Hasani, MD,MSC principal investigator
University Clinical Centre of Kosova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Propofol in people with Postoperative Pain, run by University Clinical Centre of Kosova at 1 site in Serbia.
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 2 inclusion and 4 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 27 Apr 2011. 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 Serbia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Antigona Hasani, MD, MSC (+37744402781, antigona.hasani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: 120 minutes). 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 27 Apr 2011.