To investigate the correlation between surgical pleth index and early postoperative pain/comfort in children aged 2 to 16 years of age who are undergoing surgery under general anaesthesia.
- Conditions
- Pain experienced after surgery under general anaesthesiaAnaesthesiology - Anaesthetics
- Registration Number
- ACTRN12616001139460
- Lead Sponsor
- Princess Margaret Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 105
Male or female patients, 2 to 16 years of age with an ASA of 1 2 or 3 who are scheduled for elective or urgent surgery under general anaesthesia (including laryngeal mask airway or endotracheal tube, state entropy monitoring) with sevoflurane.
Lack of informed written consent and/or child assent (where appropriate), age less than 2 years or more than 16 years, poorly treated diabetes, moderate to severe intellectual disability, severe peripheral or cardiac neuropathy, pacemaker, treatment (infusion) with vasoactive medication, any pre or intraoperative treatment prior to the 5 minute observation period with ketamine, beta-receptor blockers, clonidine (as premedication, intraoperative use, or regional adjunct), beta-receptor agonists (i.e. Ventolin) or any other drug suspected to interact with the sympatho-vagal balance.
Muscle relaxant reversal using neostigmine, atropine or glycopyrrolate during the 15 minute observation period.
Propofol used during the 5 minute SPI observation period.
Surgery requiring a tourniquet (unless already deflated at start of intra-operative data acquisition interval).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Definition of the optimum (highest combined sensitivity and specificity) cut-off value for Surgical Pleth Index (SPI) to distinguish between no to mild versus moderate to severe postoperative pain in children.<br>Pain will be measured using numerical rating scale (NRS; 0-10) for children aged 9-16, FPS-R for children aged 4-8 and FLACC for children aged 2-3. <br>Cut-off for pain scales are as follows:<br>No to mild = 0-4 and moderate to severe = 5-10 for NRS<br>No to mild = 0-4 and moderate to severe = 6-10 for FPS-R<br>No to mild = 0-4 and moderate to severe = 5-10 for FLACC<br> [In the recovery room post operation, as per routine clinical practice, a patient’s pain will be rated on an age appropriate pain scale every 5 minutes for 15 minutes once the patient is deemed conscious and non-delirious.]
- Secondary Outcome Measures
Name Time Method Assessment of a potential variation in surgical pleth index in children depending on their age undergoing surgery under general anaesthesia. Participants are split between 3 age groups: 2-3 years, 4-8 years and 9-16 years<br>[During the anticipated last 5 minutes of the surgery (last 5 minutes prior to anticipated lightening of depth of anaesthesia to state entropy > 60, period of only mild surgical stimulation [i.e. skin closure, application of plaster or wound dressing]), data (blood pressure, heart rate, SE, SPI).]