Pain Clinical Trial
Official title:
Validity of Pupil Diameter for Pain Monitoring During General Anesthesia in Children : a Prospective Observational Study
NCT number | NCT04062864 |
Other study ID # | 1906-121-1043 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 21, 2019 |
Est. completion date | July 24, 2020 |
Verified date | August 2020 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study evaluates the validity of pupil diameter as an indicator of pain during surgery under general anesthesia.
Status | Completed |
Enrollment | 35 |
Est. completion date | July 24, 2020 |
Est. primary completion date | July 24, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 12 Years |
Eligibility |
Inclusion Criteria: - Children undergoing surgery under general anesthesia with total time of less than two hours Exclusion Criteria: - Children whose parent or legal guardian declined to enroll - Any use of opioids during surgery - History of hypersensitivity to any anesthetic agents - Any medication that can affect sympathetic nervous activity - Presence of underlying ophthalmologic disease |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | SNUH | Seoul | Jongno Gu |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Aissou M, Snauwaert A, Dupuis C, Atchabahian A, Aubrun F, Beaussier M. Objective assessment of the immediate postoperative analgesia using pupillary reflex measurement: a prospective and observational study. Anesthesiology. 2012 May;116(5):1006-12. doi: 10.1097/ALN.0b013e318251d1fb. — View Citation
Barvais L, Engelman E, Eba JM, Coussaert E, Cantraine F, Kenny GN. Effect site concentrations of remifentanil and pupil response to noxious stimulation. Br J Anaesth. 2003 Sep;91(3):347-52. — View Citation
Höfle M, Kenntner-Mabiala R, Pauli P, Alpers GW. You can see pain in the eye: pupillometry as an index of pain intensity under different luminance conditions. Int J Psychophysiol. 2008 Dec;70(3):171-5. doi: 10.1016/j.ijpsycho.2008.06.008. Epub 2008 Jun 28. — View Citation
Julien-Marsollier F, Rachdi K, Caballero MJ, Ayanmanesh F, Vacher T, Horlin AL, Skhiri A, Brasher C, Michelet D, Dahmani S. Evaluation of the analgesia nociception index for monitoring intraoperative analgesia in children. Br J Anaesth. 2018 Aug;121(2):462-468. doi: 10.1016/j.bja.2018.03.034. Epub 2018 Jun 5. — View Citation
Kaye AD, Fox CJ, Padnos IW, Ehrhardt KP Jr, Diaz JH, Cornett EM, Chandler D, Sen S, Patil S. Pharmacologic Considerations of Anesthetic Agents in Pediatric Patients: A Comprehensive Review. Anesthesiol Clin. 2017 Jun;35(2):e73-e94. doi: 10.1016/j.anclin.2017.01.012. Epub 2017 Apr 14. Review. — View Citation
Mulier J, Dekock M. Opioid free general anesthesia, a new paradigm? Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):441-443. doi: 10.1016/j.bpa.2017.11.005. Epub 2017 Dec 6. — View Citation
Muller MP, Tomlinson G, Marrie TJ, Tang P, McGeer A, Low DE, Detsky AS, Gold WL. Can routine laboratory tests discriminate between severe acute respiratory syndrome and other causes of community-acquired pneumonia? Clin Infect Dis. 2005 Apr 15;40(8):1079-86. Epub 2005 Mar 16. — View Citation
Paulus J, Roquilly A, Beloeil H, Théraud J, Asehnoune K, Lejus C. Pupillary reflex measurement predicts insufficient analgesia before endotracheal suctioning in critically ill patients. Crit Care. 2013 Jul 24;17(4):R161. doi: 10.1186/cc12840. — View Citation
Sabourdin N, Barrois J, Louvet N, Rigouzzo A, Guye ML, Dadure C, Constant I. Pupillometry-guided Intraoperative Remifentanil Administration versus Standard Practice Influences Opioid Use: A Randomized Study. Anesthesiology. 2017 Aug;127(2):284-292. doi: 10.1097/ALN.0000000000001705. — View Citation
Silins V, Brasher C, Antus F, Michelet D, Hilly J, Grace R, Dahmani S. Predicting postoperative morphine consumption in children. Anaesth Crit Care Pain Med. 2017 Jun;36(3):179-184. doi: 10.1016/j.accpm.2016.08.005. Epub 2016 Oct 4. — View Citation
Sultana A, Torres D, Schumann R. Special indications for Opioid Free Anaesthesia and Analgesia, patient and procedure related: Including obesity, sleep apnoea, chronic obstructive pulmonary disease, complex regional pain syndromes, opioid addiction and cancer surgery. Best Pract Res Clin Anaesthesiol. 2017 Dec;31(4):547-560. doi: 10.1016/j.bpa.2017.11.002. Epub 2017 Nov 16. Review. — View Citation
Urban BW, Bleckwenn M. Concepts and correlations relevant to general anaesthesia. Br J Anaesth. 2002 Jul;89(1):3-16. Review. — View Citation
Wessel DL. Hemodynamic responses to perioperative pain and stress in infants. Crit Care Med. 1993 Sep;21(9 Suppl):S361-2. Review. — View Citation
Wildemeersch D, Peeters N, Saldien V, Vercauteren M, Hans G. Pain assessment by pupil dilation reflex in response to noxious stimulation in anaesthetized adults. Acta Anaesthesiol Scand. 2018 Apr 19. doi: 10.1111/aas.13129. [Epub ahead of print] — View Citation
Won YJ, Lim BG, Kim YS, Lee M, Kim H. Usefulness of surgical pleth index-guided analgesia during general anesthesia: a systematic review and meta-analysis of randomized controlled trials. J Int Med Res. 2018 Nov;46(11):4386-4398. doi: 10.1177/0300060518796749. Epub 2018 Sep 9. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pupil diameter | Pupil diameter before and after painful stimuli (skin incision, train-of-four stimulation) | From start of anesthesia to end of anesthesia | |
Secondary | Bispectral index | Bispectral index before and after painful stimuli (skin incision, train-of-four stimulation) | From start of anesthesia to end of anesthesia | |
Secondary | Pleth variability index | Pleth variability index before and after painful stimuli (skin incision, train-of-four stimulation) | From start of anesthesia to end of anesthesia |
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