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

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 N(2)O and O(2) (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) − ANI(0)) 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