Virtual reality vs. Kalinox® for management of pain in intensive care unit after cardiac surgery: a randomized study

Driss Laghlam; Cecile Naudin; Lucas Coroyer; Vincent Aidan; Julien Malvy; Ghilas Rahoual; Philippe Estagnasié; Pierre Squara

doi:10.1186/s13613-021-00866-w

Virtual reality vs. Kalinox® for management of pain in intensive care unit after cardiac surgery: a randomized study

Ann Intensive Care. 2021 May 13;11(1):74. doi: 10.1186/s13613-021-00866-w.

Authors

Driss Laghlam¹, Cecile Naudin², Lucas Coroyer³, Vincent Aidan³, Julien Malvy³, Ghilas Rahoual³, Philippe Estagnasié³, Pierre Squara³

Affiliations

¹ Department of Cardiology and Critical Care, CERIC, Clinique Ambroise Paré, 27 boulevard Victor Hugo, 92200, Neuilly-sur-Seine, France. driss.laghlam@gmail.com.
² Department of Clinical Research, Clinique Ambroise Paré, 27 boulevard Victor Hugo, 92200, Neuilly-sur-Seine, France.
³ Department of Cardiology and Critical Care, CERIC, Clinique Ambroise Paré, 27 boulevard Victor Hugo, 92200, Neuilly-sur-Seine, France.

Abstract

Introduction: The management of pain and anxiety remains a challenge in the intensive care unit. By distracting patients, virtual reality (VR) may have a role in painful procedures. We compared VR vs. an inhaled equimolar mixture of N₂O and O₂ (Kalinox®) for pain and anxiety management during the removal of chest drains after cardiac surgery.

Methods: Prospective, non-inferiority, open-label study. Patients were randomized, for Kalinox® or VR session during drain removal. The analgesia/nociception index (ANI) was monitored during the procedure for objective assessment of pain and anxiety. The primary endpoint was the ΔANI (ANI_min - ANI₀) during the procedure, based on ANIm (average on 4 min). We prespecified VR as non-inferior to Kalinox® with a margin of 3 points. Self-reported pain and anxiety were also analysed using numeric rate scale (NRS).

Results: 200 patients were included, 99 in the VR group and 101 in the Kalinox® group; 90 patients were analysed in both groups in per-protocol analysis. The median age was 68.0 years [60.0-74.8]. The ΔANI was - 15.1 ± 12.9 in the Kalinox® group and - 15.7 ± 11.6 in the VR group (NS). The mean difference was, therefore, - 0.6 [- 3.6 to 2.4], including the non-inferiority margin of 3. Patients in the VR group had a significantly higher pain NRS scale immediately after the drain removal, 5.0 [3.0-7.0] vs. 3.0 [2.0-6.0], p = 0.009, but no difference 10 min after. NRS of anxiety did not differ between the two groups.

Conclusion: Based on the ANI, the current study showed that VR did not reach the statistical requirements for a proven non-inferiority vs. Kalinox® in managing pain and anxiety during chest drain removal. Moreover, VR was less effective based on NRS. More studies are needed to determine if VR might have a place in the overall approach to pain and anxiety in intensive care units. Trial registration NCT, NCT03956264. Registered 20 May 2019, https://clinicaltrials.gov/ct2/show/NCT03956264.

Keywords: Analgesia; Cardiac surgery; Kalinox®; Perioperative pain; Virtual reality.

Associated data

ClinicalTrials.gov/NCT03956264