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Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease

BACKGROUND: Sickle cell disease (SCD) is an inherited hematological disorder where the shape of red blood cells is altered, resulting in the destruction of red blood cells, anemia, and other complications. SCD is prevalent in the southern and eastern provinces of the Arabian peninsula. The most comm...

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Autores principales: Alshahrani, Mohammed S., Asonto, Laila Perlas, El Tahan, Mohamed M., Al Sulaibikh, Amal H., Al Faraj, Sukayna Z., Al Mulhim, Abdullah A., Al Abbad, Murad F., Al Nahhash, Samar A., Aldarweesh, Moath N., Mahmoud, Alaa M., Almaghraby, Nisreen, Al Jumaan, Mohammed A., Al Junaid, Thamir O., Al Hawaj, Faisal M., AlKenany, Samar, ElSayed, Omaima F., Abdelwahab, Haitham M., Moussa, Mohamed M., Alossaimi, Bader K., Alotaibi, Shaikah K., AlMutairi, Talal M., AlSulaiman, Duaa A., Al Shahrani, Saad D., Alfaraj, Donia, Alhazzani, Waleed
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6537144/
https://www.ncbi.nlm.nih.gov/pubmed/31133061
http://dx.doi.org/10.1186/s13063-019-3394-4
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author Alshahrani, Mohammed S.
Asonto, Laila Perlas
El Tahan, Mohamed M.
Al Sulaibikh, Amal H.
Al Faraj, Sukayna Z.
Al Mulhim, Abdullah A.
Al Abbad, Murad F.
Al Nahhash, Samar A.
Aldarweesh, Moath N.
Mahmoud, Alaa M.
Almaghraby, Nisreen
Al Jumaan, Mohammed A.
Al Junaid, Thamir O.
Al Hawaj, Faisal M.
AlKenany, Samar
ElSayed, Omaima F.
Abdelwahab, Haitham M.
Moussa, Mohamed M.
Alossaimi, Bader K.
Alotaibi, Shaikah K.
AlMutairi, Talal M.
AlSulaiman, Duaa A.
Al Shahrani, Saad D.
Alfaraj, Donia
Alhazzani, Waleed
author_facet Alshahrani, Mohammed S.
Asonto, Laila Perlas
El Tahan, Mohamed M.
Al Sulaibikh, Amal H.
Al Faraj, Sukayna Z.
Al Mulhim, Abdullah A.
Al Abbad, Murad F.
Al Nahhash, Samar A.
Aldarweesh, Moath N.
Mahmoud, Alaa M.
Almaghraby, Nisreen
Al Jumaan, Mohammed A.
Al Junaid, Thamir O.
Al Hawaj, Faisal M.
AlKenany, Samar
ElSayed, Omaima F.
Abdelwahab, Haitham M.
Moussa, Mohamed M.
Alossaimi, Bader K.
Alotaibi, Shaikah K.
AlMutairi, Talal M.
AlSulaiman, Duaa A.
Al Shahrani, Saad D.
Alfaraj, Donia
Alhazzani, Waleed
author_sort Alshahrani, Mohammed S.
collection PubMed
description BACKGROUND: Sickle cell disease (SCD) is an inherited hematological disorder where the shape of red blood cells is altered, resulting in the destruction of red blood cells, anemia, and other complications. SCD is prevalent in the southern and eastern provinces of the Arabian peninsula. The most common complications for individuals with SCD are acute painful episodes that require several doses of intravenous opioids, making pain control for these individuals challenging. Instead of opioids, some studies have suggested that ketamine might be used for pain control in acute pain episodes of individuals with SCD. This study aims to evaluate whether the addition of ketamine to morphine can achieve better pain control, decreasing the number of repeated doses of opiates. We hypothesize that early administration of ketamine would lead to a more rapid improvement in pain score and lower opioid requirements. METHODS AND ANALYSIS: This study will be a prospective, randomized, concealed, blinded, pragmatic parallel group, controlled trial enrolling adult patients with SCD and acute vaso-occlusive crisis pain. All patients will receive standard analgesic therapy during evaluation. Patients randomized to the treatment arm will receive low-dose ketamine (0.3 mg/kg in 0.9% sodium chloride, 100 ml bag) in addition to standard intravenous hydration, while those in the control group will receive a standard dose of morphine (0.1 mg/kg in 0.9% sodium chloride, 100 ml bag) in addition to the standard intravenous hydration. All healthcare providers will be blinded to the treatment arm. Data will be analyzed according to the intention-to-treat principle. The primary outcome is improvement in pain severity using the Numerical Pain Rating Score. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03431285. Registered on 13 February 2018 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3394-4) contains supplementary material, which is available to authorized users.
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spelling pubmed-65371442019-05-30 Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease Alshahrani, Mohammed S. Asonto, Laila Perlas El Tahan, Mohamed M. Al Sulaibikh, Amal H. Al Faraj, Sukayna Z. Al Mulhim, Abdullah A. Al Abbad, Murad F. Al Nahhash, Samar A. Aldarweesh, Moath N. Mahmoud, Alaa M. Almaghraby, Nisreen Al Jumaan, Mohammed A. Al Junaid, Thamir O. Al Hawaj, Faisal M. AlKenany, Samar ElSayed, Omaima F. Abdelwahab, Haitham M. Moussa, Mohamed M. Alossaimi, Bader K. Alotaibi, Shaikah K. AlMutairi, Talal M. AlSulaiman, Duaa A. Al Shahrani, Saad D. Alfaraj, Donia Alhazzani, Waleed Trials Study Protocol BACKGROUND: Sickle cell disease (SCD) is an inherited hematological disorder where the shape of red blood cells is altered, resulting in the destruction of red blood cells, anemia, and other complications. SCD is prevalent in the southern and eastern provinces of the Arabian peninsula. The most common complications for individuals with SCD are acute painful episodes that require several doses of intravenous opioids, making pain control for these individuals challenging. Instead of opioids, some studies have suggested that ketamine might be used for pain control in acute pain episodes of individuals with SCD. This study aims to evaluate whether the addition of ketamine to morphine can achieve better pain control, decreasing the number of repeated doses of opiates. We hypothesize that early administration of ketamine would lead to a more rapid improvement in pain score and lower opioid requirements. METHODS AND ANALYSIS: This study will be a prospective, randomized, concealed, blinded, pragmatic parallel group, controlled trial enrolling adult patients with SCD and acute vaso-occlusive crisis pain. All patients will receive standard analgesic therapy during evaluation. Patients randomized to the treatment arm will receive low-dose ketamine (0.3 mg/kg in 0.9% sodium chloride, 100 ml bag) in addition to standard intravenous hydration, while those in the control group will receive a standard dose of morphine (0.1 mg/kg in 0.9% sodium chloride, 100 ml bag) in addition to the standard intravenous hydration. All healthcare providers will be blinded to the treatment arm. Data will be analyzed according to the intention-to-treat principle. The primary outcome is improvement in pain severity using the Numerical Pain Rating Score. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03431285. Registered on 13 February 2018 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3394-4) contains supplementary material, which is available to authorized users. BioMed Central 2019-05-27 /pmc/articles/PMC6537144/ /pubmed/31133061 http://dx.doi.org/10.1186/s13063-019-3394-4 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Alshahrani, Mohammed S.
Asonto, Laila Perlas
El Tahan, Mohamed M.
Al Sulaibikh, Amal H.
Al Faraj, Sukayna Z.
Al Mulhim, Abdullah A.
Al Abbad, Murad F.
Al Nahhash, Samar A.
Aldarweesh, Moath N.
Mahmoud, Alaa M.
Almaghraby, Nisreen
Al Jumaan, Mohammed A.
Al Junaid, Thamir O.
Al Hawaj, Faisal M.
AlKenany, Samar
ElSayed, Omaima F.
Abdelwahab, Haitham M.
Moussa, Mohamed M.
Alossaimi, Bader K.
Alotaibi, Shaikah K.
AlMutairi, Talal M.
AlSulaiman, Duaa A.
Al Shahrani, Saad D.
Alfaraj, Donia
Alhazzani, Waleed
Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease
title Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease
title_full Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease
title_fullStr Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease
title_full_unstemmed Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease
title_short Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease
title_sort study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6537144/
https://www.ncbi.nlm.nih.gov/pubmed/31133061
http://dx.doi.org/10.1186/s13063-019-3394-4
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