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_2O 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