Pediatric anesthesia & critical care

Cryoanalgesia for Pain Management After Pectus Excavatum Repair (COPPER) in Adolescents: A Randomized Controlled Trial

Paediatr AnaesthPublished Randomised controlled trial

Primary result · PedsQLResult — go to the resultDifference 6.5 95% CI 0.46–13

Authors' conclusion

Cryoanalgesia did not improve return to baseline quality of life 2 weeks after surgery. However, it showed to be beneficial in the psychosocial component of the PedsQL scale.

Study context

Population
Adolescents undergoing minimally invasive pectus excavatum repair, Istituto Gaslini, Genova, Italy
Participants
88 adolescents
Comparison
Cryoanalgesia vs standard of care
  • Cryoanalgesian = 45
  • Standard of caren = 43reference
Primary endpoint
Pediatric Quality of Life (PedsQL) and subcomponents (psychosocial and physical health)
Follow-up
14 days after surgery
Methodological detailsactive controlled, parallel groups, Conducted between February 2022 and October 2023
  • Active controlled
  • Parallel groups
  • Conducted between February 2022 and October 2023

Primary result

PedsQL · 14th day

Difference

6.5

95% CI 0.46–13

P = 0.07

By group

Cryoanalgesia

59.8

median · IQR 48.4–71.2

Standard of care

67.9

median · IQR 58.7–73.9

Standard of care vs Cryoanalgesia
difference 6.5 (95% CI 0.46–13); P = 0.07

As reported in the abstract

Further findings

OutcomeStandard of careDifference (95% CI)P value
PedsQL, per-protocol analysis · 14th dayPP analysismedian 69.02 (IQR 58.70–73.91)7.4 (0.82–14)P = 0.028

PedsQL subcomponents, decrease within arm

Psychosocial health: more marked decrease in standard of care arm
q-value = 0.028
Psychosocial health: decrease in cryoanalgesia arm not significant
q-value = 0.056
Significant decrease in PedsQL total score and subcomponents irrespective of treatment; physical health decreased in both arms

Original publication

Cryoanalgesia for Pain Management After Pectus Excavatum Repair (COPPER) in Adolescents: A Randomized Controlled Trial. Paediatr Anaesth. Published 4 March 2025. doi:10.1111/pan.15090

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