A1 Refereed original research article in a scientific journal
Preemptive Pregabalin in Children and Adolescents Undergoing Posterior Instrumented Spinal Fusion: A Double-Blinded, Placebo-Controlled, Randomized Clinical Trial
Authors: Linda L. Helenius, Hanna Oksanen, Markus Lastikka, Olli Pajulo, Eliisa Löyttyniemi, Tuula Manner, Ilkka J. Helenius
Publisher: NLM (Medline)
Publication year: 2020
Journal: Journal of Bone and Joint Surgery, American Volume
Journal name in source: The Journal of bone and joint surgery. American volume
Volume: 102
Issue: 3
First page : 205
Last page: 212
Number of pages: 8
ISSN: 1535-1386
eISSN: 1535-1386
DOI: https://doi.org/10.2106/JBJS.19.00650
Self-archived copy’s web address: https://helda.helsinki.fi/bitstream/10138/326376/1/Preemptive_Pregabalin_helenius.pdf
Background: Pregabalin as part of a multimodal
pain-management regimen has been shown to reduce opioid consumption
after spinal surgery in adults but it is unclear whether this is also
true in adolescents. Pregabalin has been found to have neuroprotective
effects and therefore could have a positive impact on pain after spinal
deformity surgery. We conducted a randomized, double-blinded,
placebo-controlled clinical trial of adolescent patients undergoing
spinal fusion to evaluate the short-term effects of pregabalin on
postoperative pain and opioid consumption.
Methods: Adolescents with adolescent idiopathic
scoliosis, Scheuermann kyphosis, or spondylolisthesis who were scheduled
for posterior spinal fusion with all-pedicle-screw instrumentation were
randomized to receive either pregabalin (2 mg/kg twice daily) or
placebo preoperatively and for 5 days after surgery. The patients ranged
from 10 to 21 years of age. The primary outcome was total opioid
consumption as measured with use of patient-controlled analgesia.
Postoperative pain scores and opioid-related adverse effects were
evaluated.
Results: Sixty-three of 77 eligible patients were
included and analyzed. Cumulative oxycodone consumption per kilogram did
not differ between the study groups during the first 48 hours
postoperatively, with a median of 1.44 mg/kg (95% confidence interval
[CI],1.32 to 1.67 mg/kg) in the pregabalin group and 1.50 mg/kg (95% CI,
1.39 to 1.79 mg/kg) in the placebo group (p = 0.433). A subgroup
analysis of 51 patients with adolescent idiopathic scoliosis showed the
same result, with a mean of 1.45 mg/kg (95% CI, 1.24 to 1.65 mg/kg) in
the pregabalin group and 1.59 mg/kg (95% CI, 1.37 to 1.82 mg/kg) in the
placebo group (p = 0.289). Total oxycodone consumption per hour
(mg/kg/hr) was not different between the groups over the time points (p =
0.752). The postoperative pain scores did not differ significantly
between the groups (p = 0.196).
Conclusions: The use of perioperative pregabalin does
not reduce the postoperative opioid consumption or pain scores in
adolescents after posterior spinal fusion surgery.
Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
