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Oral sedation for pain with cervical dilator placement: a randomized controlled trial()()

OBJECTIVE: Assess oral sedation versus placebo for pain control with cervical dilator placement. STUDY DESIGN: We randomized participants presenting for dilation and evacuation to lorazepam 1 mg/oxycodone 5 mg or placebo 45 min before cervical dilator placement. Our primary outcome was median visual...

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Autores principales: Lee, Jessica K., Burke, Anne E., Thaler, Katrina, Robinson, Jennifer A., Sufrin, Carolyn
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7815458/
https://www.ncbi.nlm.nih.gov/pubmed/33506195
http://dx.doi.org/10.1016/j.conx.2020.100053
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author Lee, Jessica K.
Burke, Anne E.
Thaler, Katrina
Robinson, Jennifer A.
Sufrin, Carolyn
author_facet Lee, Jessica K.
Burke, Anne E.
Thaler, Katrina
Robinson, Jennifer A.
Sufrin, Carolyn
author_sort Lee, Jessica K.
collection PubMed
description OBJECTIVE: Assess oral sedation versus placebo for pain control with cervical dilator placement. STUDY DESIGN: We randomized participants presenting for dilation and evacuation to lorazepam 1 mg/oxycodone 5 mg or placebo 45 min before cervical dilator placement. Our primary outcome was median visual analog scale (VAS) pain score after dilator placement using a 100-mm VAS. We used our outcome data to calculate median pain score changes from baseline to better reflect pain score differences between study groups. Planned sample size was 30 participants per group, for a total of 60. RESULTS: We randomized 27 participants; 9 received sedation and 11 placebo. Median pain score increase from baseline to last dilator placement was 20 [interquartile range (IQR) 8–29] and 31 (IQR 15–81) in the oral sedation and placebo groups, p = .16. CONCLUSION: We were unable to enroll our desired sample size, and our sample is underpowered to make any conclusions. Our results suggest that oral sedation may provide some benefit for pain relief with dilator insertion and indicate that further research might be worthwhile especially in settings that do not routinely provide these analgesics. IMPLICATIONS: We had difficulty with study recruitment because many patients desired oral sedation for pain management for cervical dilator placement and declined randomization. Randomized trials of pain management with a placebo arm may find recruitment challenging especially if default clinical care already includes a pain management option that patients would have to opt out of.
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spelling pubmed-78154582021-01-26 Oral sedation for pain with cervical dilator placement: a randomized controlled trial()() Lee, Jessica K. Burke, Anne E. Thaler, Katrina Robinson, Jennifer A. Sufrin, Carolyn Contracept X Article OBJECTIVE: Assess oral sedation versus placebo for pain control with cervical dilator placement. STUDY DESIGN: We randomized participants presenting for dilation and evacuation to lorazepam 1 mg/oxycodone 5 mg or placebo 45 min before cervical dilator placement. Our primary outcome was median visual analog scale (VAS) pain score after dilator placement using a 100-mm VAS. We used our outcome data to calculate median pain score changes from baseline to better reflect pain score differences between study groups. Planned sample size was 30 participants per group, for a total of 60. RESULTS: We randomized 27 participants; 9 received sedation and 11 placebo. Median pain score increase from baseline to last dilator placement was 20 [interquartile range (IQR) 8–29] and 31 (IQR 15–81) in the oral sedation and placebo groups, p = .16. CONCLUSION: We were unable to enroll our desired sample size, and our sample is underpowered to make any conclusions. Our results suggest that oral sedation may provide some benefit for pain relief with dilator insertion and indicate that further research might be worthwhile especially in settings that do not routinely provide these analgesics. IMPLICATIONS: We had difficulty with study recruitment because many patients desired oral sedation for pain management for cervical dilator placement and declined randomization. Randomized trials of pain management with a placebo arm may find recruitment challenging especially if default clinical care already includes a pain management option that patients would have to opt out of. Elsevier 2021-01-07 /pmc/articles/PMC7815458/ /pubmed/33506195 http://dx.doi.org/10.1016/j.conx.2020.100053 Text en © 2021 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Lee, Jessica K.
Burke, Anne E.
Thaler, Katrina
Robinson, Jennifer A.
Sufrin, Carolyn
Oral sedation for pain with cervical dilator placement: a randomized controlled trial()()
title Oral sedation for pain with cervical dilator placement: a randomized controlled trial()()
title_full Oral sedation for pain with cervical dilator placement: a randomized controlled trial()()
title_fullStr Oral sedation for pain with cervical dilator placement: a randomized controlled trial()()
title_full_unstemmed Oral sedation for pain with cervical dilator placement: a randomized controlled trial()()
title_short Oral sedation for pain with cervical dilator placement: a randomized controlled trial()()
title_sort oral sedation for pain with cervical dilator placement: a randomized controlled trial()()
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7815458/
https://www.ncbi.nlm.nih.gov/pubmed/33506195
http://dx.doi.org/10.1016/j.conx.2020.100053
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