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

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 (ANImin - 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://ichgcp.net/clinical-trials-registry/NCT03956264.

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

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart
Fig. 2
Fig. 2
ANI variation during procedure. ANI values 0–100 points (low values indicating higher levels of pain). ANI analgesia/nociception index, VR virtual reality
Fig. 3
Fig. 3
NRS pain variation during procedure. NRS pain (0–10) in the VR and Kalinox groups before, immediately after, and 10 min after chest drain removal. Data are represented as median with interquartile range. NRS numerical rating scale, VR virtual reality

References

    1. Puntillo KA, Max A, Timsit JF, Vignoud L, Chanques G, Robleda G, et al. Determinants of procedural pain intensity in the intensive care unit. The Europain® study. Am J Respir Crit Care Med. 2014;189(1):39–47.
    1. Gift AG, Bolgiano CS, Cunningham J. Sensations during chest tube removal. Heart Lung. 1991;20(2):131–137.
    1. Schelling G, Richter M, Roozendaal B, Rothenhäusler HB, Krauseneck T, Stoll C, et al. Exposure to high stress in the intensive care unit may have negative effects on health-related quality-of-life outcomes after cardiac surgery. Crit Care Med. 2003;31(7):1971–1980. doi: 10.1097/01.CCM.0000069512.10544.40.
    1. Carson MM, Barton DM, Morrison CC, Tribble CG. Managing pain during mediastinal chest tube removal. Heart Lung. 1994;23(6):500–505.
    1. Bruce EA, Howard RF, Franck LS. Chest drain removal pain and its management: a literature review. J Clin Nurs. 2006;15(2):145–154. doi: 10.1111/j.1365-2702.2006.01273.x.
    1. Akrofi M, Miller S, Colfar S, Corry PR, Fabri BM, Pullan MD, et al. A randomized comparison of three methods of analgesia for chest drain removal in postcardiac surgical patients. Anesth Analg. 2005;100(1):205–209. doi: 10.1213/01.ANE.0000140237.96510.E5.
    1. Brotzman EA, Sandoval LF, Crane J. Use of nitrous oxide in dermatology: a systematic review. Dermatol Surg. 2018;44(5):661–669. doi: 10.1097/DSS.0000000000001464.
    1. Buhre W, Disma N, Hendrickx J, DeHert S, Hollmann MW, Huhn R, et al. European society of anaesthesiology task force on nitrous oxide: a narrative review of its role in clinical practice. Br J Anaesth. 2019;122(5):587–604. doi: 10.1016/j.bja.2019.01.023.
    1. Gao LL, Yu JQ, Liu Q, Gao HX, Dai YL, Zhang JJ, et al. Analgesic effect of nitrous oxide/oxygen mixture for traumatic pain in the emergency department: a randomized, double-blind study. J Emerg Med. 2019;57(4):444–452. doi: 10.1016/j.jemermed.2019.06.026.
    1. Thompson JM, Neave N, Moss MC, Scholey AB, Wesnes K, Girdler NM. Comparison of Entonox and low-dose premixed isoflurane and desflurane for chest drain removal after cardiac surgery. Br J Anaesth. 1999;8:175–176.
    1. Pourmand A, Davis S, Lee D, Barber S, Sikka N. Emerging utility of virtual reality as a multidisciplinary tool in clinical medicine. Games Health J. 2017;6(5):263–270. doi: 10.1089/g4h.2017.0046.
    1. Chan E, Foster S, Sambell R, Leong P. Clinical efficacy of virtual reality for acute procedural pain management: a systematic review and meta-analysis. PLoS ONE. 2018;13(7):e0200987. doi: 10.1371/journal.pone.0200987.
    1. Safikhani S, Gries KS, Trudeau JJ, Reasner D, Rüdell K, Coons SJ, et al. Response scale selection in adult pain measures: results from a literature review. J Patient Rep Outcomes. 2017;2:40. doi: 10.1186/s41687-018-0053-6.
    1. Devlin JW, Skrobik Y, Gélinas C, Needham DM, Slooter AJC, Pandharipande PP, et al. Executive summary: clinical practice guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU. Crit Care Med. 2018;46(9):1532–1548. doi: 10.1097/CCM.0000000000003259.
    1. Logier R, Jeanne M, De Jonckheere J, Dassonneville A, Delecroix M, Tavernier B. PhysioDoloris: a monitoring device for analgesia/nociception balance evaluation using heart rate variability analysis. In: 2010 annual international conference of the IEEE engineering in medicine and biology. 2010. p. 1194–7.
    1. Pichot V, Gaspoz JM, Molliex S, Antoniadis A, Busso T, Roche F, et al. Wavelet transform to quantify heart rate variability and to assess its instantaneous changes. J Appl Physiol. 1999;86(3):1081–1091. doi: 10.1152/jappl.1999.86.3.1081.
    1. Theerth KA, Sriganesh K, Reddy KM, Chakrabarti D, Umamaheswara Rao GS. Analgesia Nociception Index-guided intraoperative fentanyl consumption and postoperative analgesia in patients receiving scalp block versus incision-site infiltration for craniotomy. Minerva Anestesiol. 2018;84(12):1361–1368. doi: 10.23736/S0375-9393.18.12837-9.
    1. Boselli E, Bouvet L, Bégou G, Dabouz R, Davidson J, Deloste JY, et al. Prediction of immediate postoperative pain using the analgesia/nociception index: a prospective observational study. Br J Anaesth. 2014;112(4):715–721. doi: 10.1093/bja/aet407.
    1. Abdullayev R, Yildirim E, Celik B, Topcu Sarica L. Analgesia Nociception Index: heart rate variability analysis of emotional status. Cureus. 2019;11(4):e4365.
    1. Chanques G, Tarri T, Ride A, Prades A, De Jong A, Carr J, et al. Analgesia nociception index for the assessment of pain in critically ill patients: a diagnostic accuracy study. Br J Anaesth. 2017;119(4):812–820. doi: 10.1093/bja/aex210.
    1. Benner A. Sample size tables for clinical studies. (2nd edn). David Machin, Michael J. Campbell, Peter M. Fayers and Alain P. Y. Pinol, Blackwell Science Ltd., Oxford, 1997. No. of pages: x+315. Price: £45. ISBN 0-86542-870-0. Statistics in Medicine. 1999;18(4):494–5.
    1. Walker MR, Kallingal GJ, Musser JE, Folen R, Stetz MC, Clark JY. Treatment efficacy of virtual reality distraction in the reduction of pain and anxiety during cystoscopy. Mil Med. 2014;179(8):891–896. doi: 10.7205/MILMED-D-13-00343.
    1. Kipping B, Rodger S, Miller K, Kimble RM. Virtual reality for acute pain reduction in adolescents undergoing burn wound care: a prospective randomized controlled trial. Burns. 2012;38(5):650–657. doi: 10.1016/j.burns.2011.11.010.
    1. Garrett B, Taverner T, Masinde W, Gromala D, Shaw C, Negraeff M. A rapid evidence assessment of immersive virtual reality as an adjunct therapy in acute pain management in clinical practice. Clin J Pain. 2014;30(12):1089–1098. doi: 10.1097/AJP.0000000000000064.
    1. Nikayin S, Rabiee A, Hashem MD, Huang M, Bienvenu OJ, Turnbull AE, et al. Anxiety symptoms in survivors of critical illness: a systematic review and meta-analysis. Gen Hosp Psychiatry. 2016;43:23–29. doi: 10.1016/j.genhosppsych.2016.08.005.
    1. Takagi H, Ando T, Umemoto T. Perioperative depression or anxiety and postoperative mortality in cardiac surgery: a systematic review and meta-analysis. Heart Vessels. 2017;32(12):1458–1468. doi: 10.1007/s00380-017-1022-3.
    1. Pochard F, Bellivier F, Faessel AI, Squara P. Anxiety and depressive disorders in cardiovascular diseases. Encephale. 1997;23(6):412–419.
    1. Won AS, Bailey J, Bailenson J, Tataru C, Yoon IA, Golianu B. Immersive virtual reality for pediatric pain. Children. 2017;4(7):52. doi: 10.3390/children4070052.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj