Pain management in children with cerebral palsy undergoing single-event multilevel surgery

Study Type: Therapy
OE Level of Evidence: 2
Journal Level of Evidence: N/A
Synopsis
50 children with cerebral palsy scheduled for single-event multilevel surgery (SEMLS) were included in this randomized trial. Each patient received general anesthesia and then epidural analgesia with bupivacaine and either clonidine or standard fentanyl , according to randomization. The purpose of Please login to view the rest of this report. Please login to view the rest of this report.
Funding: Non-Industry funded
Sponsor: Victorian Government’s Operational Infrastructure Program
Conflicts: Other
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Why was this study needed now?
In children with cerebral palsy, regular growth and maturation can worsen musculoskeletal pathology in the limbs by inducing contractures, bony torsion, and joint instability. As a result, these patients may undergo several corrective orthopaedic procedures, otherwise known as single-event multilevel surgery (SEMLS). Sufficient pain management following these surgical procedures is critical to postoperative healing and early rehabilitation. Epidural infusion of bupivacaine and fentanyl has been reported to provide significant pain relief, however, side-effects such as increased risk of pruritus and emesis must be considered prior to administration. Alternatively, epidural clonidine may potentially allow for similar pain relief while reducing these side effects in addition to having anti-spasm properties and minimal respiratory depressive consequences. Therefore, the aim of this study was to compare pain relief and several clinical side effects for patients given epidural bupivacaine with either fentanyl or clonidine.
What was the principal research question?
For pediatric patients with cerebral palsy undergoing single-event multilevel surgery (SEMLS), is the addition of clonidine to epidural bupivacaine associated with significantly reduced diazepam use, muscle spasm, pain relief, and side effects when compared to fentanyl with bupivacaine, as assessed up to 72 hours post-surgery?
Population: 50 children with cerebral palsy undergoing single-event multilevel surgery (SEMLS) were included in this study. SEMLS was predefined as undergoing at least one surgical procedure performed on two different lower extremity anatomic levels. All patients were given general anaesthesia consisting of propofol 3-5 mg/kg or sevoflurane 8% and nitrous oxide in 30% oxygen. Patients were additionally given atracurium 0.5mg/kg, metoclopramide 0.4mg/kg, cephazolin 20mg/kg, and Ringer’s solution (the latter of which was used for fasting deficit). If baseline blood pressure decreased more than 20%, a fluid bolus of colloid solution was given.
Intervention: Clonidine group: patients received a loading dose of 0.25% bupivacaine (0.5 mL/kg, to a maximum of 15 mL) mixed with 2.5 micrograms/mL of clonidine over a five minute period, followed by 0.125% bupivacaine and 2.5 microgram/mL doses administered at 0.25 mL/kg/h one hour later and throughout a 72-hour postoperative period (n=25, 24 completed follow-up; mean age= 10 years, 11 months [+/- 2 years, 10 months], 12M/12F).
Comparison: Fentanyl group: patients received a loading dose of 0.25% bupivacaine (0.5 mL/kg, to a maximum of 15 mL) mixed with 2.0 micrograms/mL of fentanyl over a five minute period, followed by 0.125% bupivacaine and 2.0 microgram/mL doses administered at 0.25 mL/kg/h one hour later and throughout a 72-hour postoperative period (n=25, 25 completed follow-up; mean age= 10 years, 10 months [+/- 2 years, 11 months], 15M/10F).
Outcomes: The primary outcome was diazepam use. Secondary outcomes included muscle spasm score (Likert 0-2 scale, where 0= no spasm, 1= non-painful spasm, and 2=painful spasm), epidural interventions (boluses of rate change or withdrawal of catheter), diazepam or paracetamol administration, emesis, administration of anti-emetics (0.2 mg/kg metoclopramide), blood pressure (where hypotension was defined as a 20% drop in baseline blood pressure), temperature, Heart rate, arterial oxygen, respiratory rate, sedation score (Likert 0-4 scale), and adverse events were monitored and evaluated throughout study duration.
Methods: RCT: prospective; anaesthetist-, surgeon-, patient-, and nurse-blinded; single-center
Time: Outcomes of interest were evaluated every hour throughout a 72-hour observational period.
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The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.