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Pregabalin in the reduction of pain and opioid consumption after burn injuries: A preliminary, randomized, double-blind, placebo-controlled study

BACKGROUND: The primary objective of the study was to evaluate the efficacy of 300 milligrams (mg) and 600 mg of pregabalin compared to placebo in the reduction of pain in patients with noncritical partial and full thickness burn injuries. METHODS: A prospective, randomized, double-blinded, single c...

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Autores principales: Jones, Larry M., Uribe, Alberto A., Coffey, Rebecca, Puente, Erika G., Abdel-Rasoul, Mahmoud, Murphy, Claire V., Bergese, Sergio D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6504294/
https://www.ncbi.nlm.nih.gov/pubmed/31045775
http://dx.doi.org/10.1097/MD.0000000000015343
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author Jones, Larry M.
Uribe, Alberto A.
Coffey, Rebecca
Puente, Erika G.
Abdel-Rasoul, Mahmoud
Murphy, Claire V.
Bergese, Sergio D.
author_facet Jones, Larry M.
Uribe, Alberto A.
Coffey, Rebecca
Puente, Erika G.
Abdel-Rasoul, Mahmoud
Murphy, Claire V.
Bergese, Sergio D.
author_sort Jones, Larry M.
collection PubMed
description BACKGROUND: The primary objective of the study was to evaluate the efficacy of 300 milligrams (mg) and 600 mg of pregabalin compared to placebo in the reduction of pain in patients with noncritical partial and full thickness burn injuries. METHODS: A prospective, randomized, double-blinded, single center, placebo-controlled trial was conducted. Simple randomization method was used in this trial. After subjects met all the inclusion and none of the exclusion criteria, they were randomized and assigned to 1 of the 3 18-day treatments groups: Pregabalin 300 group, Pregabalin 600 group, or Placebo group. Demographics and clinical characteristics were recorded. The severity of pain was assessed by using the visual analog scale for pain intensity at baseline on day 3, day 9 ± 3, day 25 ± 7, day 90 ± 6, and day 180 ± 12. RESULTS: A total of 54 subjects were randomly assigned, and 51 were included in the data analysis. Demographics and clinical characteristics did not differ significantly between the 3 groups. There was a statistically significant difference in pain between the Pregabalin 300 and Pregabalin 600 groups (P-value = .0260). The Pregabalin 300 group had 17.93 units (95% confidence interval: 1.83–34.04) higher pain scores on average than the Pregabalin 600 group, regardless of time. The adjusted P-value comparing 0 to 300 was .1618, while the adjusted P-value for 0 versus 600 was .5304. There was an overall difference in pain across time regardless of study group (P-value = <.0001). An overall difference in opioid consumption (P-value = .0003) and BSHS (P-value = .0013) across time regardless of study group was noted. CONCLUSIONS: Pregabalin could be part of a promising multimodal analgesic regimen in noncritical burn population. Future placebo-controlled studies assessing the use of pregabalin in burn victim patients may further endorse our findings.
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spelling pubmed-65042942019-05-29 Pregabalin in the reduction of pain and opioid consumption after burn injuries: A preliminary, randomized, double-blind, placebo-controlled study Jones, Larry M. Uribe, Alberto A. Coffey, Rebecca Puente, Erika G. Abdel-Rasoul, Mahmoud Murphy, Claire V. Bergese, Sergio D. Medicine (Baltimore) Research Article BACKGROUND: The primary objective of the study was to evaluate the efficacy of 300 milligrams (mg) and 600 mg of pregabalin compared to placebo in the reduction of pain in patients with noncritical partial and full thickness burn injuries. METHODS: A prospective, randomized, double-blinded, single center, placebo-controlled trial was conducted. Simple randomization method was used in this trial. After subjects met all the inclusion and none of the exclusion criteria, they were randomized and assigned to 1 of the 3 18-day treatments groups: Pregabalin 300 group, Pregabalin 600 group, or Placebo group. Demographics and clinical characteristics were recorded. The severity of pain was assessed by using the visual analog scale for pain intensity at baseline on day 3, day 9 ± 3, day 25 ± 7, day 90 ± 6, and day 180 ± 12. RESULTS: A total of 54 subjects were randomly assigned, and 51 were included in the data analysis. Demographics and clinical characteristics did not differ significantly between the 3 groups. There was a statistically significant difference in pain between the Pregabalin 300 and Pregabalin 600 groups (P-value = .0260). The Pregabalin 300 group had 17.93 units (95% confidence interval: 1.83–34.04) higher pain scores on average than the Pregabalin 600 group, regardless of time. The adjusted P-value comparing 0 to 300 was .1618, while the adjusted P-value for 0 versus 600 was .5304. There was an overall difference in pain across time regardless of study group (P-value = <.0001). An overall difference in opioid consumption (P-value = .0003) and BSHS (P-value = .0013) across time regardless of study group was noted. CONCLUSIONS: Pregabalin could be part of a promising multimodal analgesic regimen in noncritical burn population. Future placebo-controlled studies assessing the use of pregabalin in burn victim patients may further endorse our findings. Wolters Kluwer Health 2019-05-03 /pmc/articles/PMC6504294/ /pubmed/31045775 http://dx.doi.org/10.1097/MD.0000000000015343 Text en Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by-nc/4.0 This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc/4.0
spellingShingle Research Article
Jones, Larry M.
Uribe, Alberto A.
Coffey, Rebecca
Puente, Erika G.
Abdel-Rasoul, Mahmoud
Murphy, Claire V.
Bergese, Sergio D.
Pregabalin in the reduction of pain and opioid consumption after burn injuries: A preliminary, randomized, double-blind, placebo-controlled study
title Pregabalin in the reduction of pain and opioid consumption after burn injuries: A preliminary, randomized, double-blind, placebo-controlled study
title_full Pregabalin in the reduction of pain and opioid consumption after burn injuries: A preliminary, randomized, double-blind, placebo-controlled study
title_fullStr Pregabalin in the reduction of pain and opioid consumption after burn injuries: A preliminary, randomized, double-blind, placebo-controlled study
title_full_unstemmed Pregabalin in the reduction of pain and opioid consumption after burn injuries: A preliminary, randomized, double-blind, placebo-controlled study
title_short Pregabalin in the reduction of pain and opioid consumption after burn injuries: A preliminary, randomized, double-blind, placebo-controlled study
title_sort pregabalin in the reduction of pain and opioid consumption after burn injuries: a preliminary, randomized, double-blind, placebo-controlled study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6504294/
https://www.ncbi.nlm.nih.gov/pubmed/31045775
http://dx.doi.org/10.1097/MD.0000000000015343
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