Postoperative Pain
Conditions
Keywords
propofol, sevoflurane, postoperative pain, children
Brief summary
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.
Interventions
DRUGPropofol
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.
Sponsors
University Clinical Centre of Kosova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* allergy to any of the drugs * preoperative anxiety * postoperative agitation * ASA physical status \>II
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | 120 minutes | The Faces Pain Scale (FPS) (from five face drawings: 0 = no pain, 5 = extreme pain) is used to assess pain severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| recovery time | 120 minutes | Recovery time, defined as the time until eye opening on command or the time of first response to command after anesthesia |
| adverse effects | 0-120 minutes | Adverse effects during the surgery and after recovery: hypotension, bradicardia, intense coughing, hypersalivation and laryngospasm, nausea, and vomiting. |
Countries
Serbia
Contacts
Primary ContactAntigona Hasani, MD, MSC
Backup ContactAntiogna Hasani
Outcome results
None listed