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Salbutamol for analgesia in renal colic: study protocol for a prospective, randomised, placebo-controlled phase II trial (SARC)
BACKGROUND: Renal colic is the pain experienced by a patient when a renal calculus (kidney stone) causes partial or complete obstruction of part of the renal outflow tract. The standard analgesic regimes for renal colic are often ineffective; in some studies, less than half of patients achieve compl...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9036510/ https://www.ncbi.nlm.nih.gov/pubmed/35468847 http://dx.doi.org/10.1186/s13063-022-06225-9 |
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author | Johnson, Graham Tabner, Andrew Fakis, Apostolos Sherman, Rachelle Chester, Victoria Bedford, Elizabeth Jackson, Richard Ratan, Hari Mason, Suzanne |
author_facet | Johnson, Graham Tabner, Andrew Fakis, Apostolos Sherman, Rachelle Chester, Victoria Bedford, Elizabeth Jackson, Richard Ratan, Hari Mason, Suzanne |
author_sort | Johnson, Graham |
collection | PubMed |
description | BACKGROUND: Renal colic is the pain experienced by a patient when a renal calculus (kidney stone) causes partial or complete obstruction of part of the renal outflow tract. The standard analgesic regimes for renal colic are often ineffective; in some studies, less than half of patients achieve complete pain relief, and a large proportion of patients require rescue analgesia within 4 h. Current analgesic regimes are also associated with significant side effects including nausea, vomiting, drowsiness and respiratory depression. It has been hypothesised that beta adrenoreceptor agonists, such as salbutamol, may reduce the pain of renal colic. They have been shown to impact a number of factors that target the physiological causes of pain in renal colic (ureteric spasm and increased peristalsis, increased pressure at the renal pelvis and prostaglandin release with inflammation). There is biological plausibility and a body of evidence sufficient to suggest that this novel treatment for the pain of renal colic should be taken to a phase II clinical trial. The aim of this trial is to test whether salbutamol is an efficacious analgesic adjunct when added to the standard analgesic regime for patients presenting to the ED with subsequently confirmed renal colic. METHODS: A phase II, randomised, placebo-controlled trial will be performed in an acute NHS Trust in the East Midlands. Patients presenting to the emergency department with pain requiring IV analgesia and working diagnosis of renal colic will be randomised to receive standard analgesia ± a single intravenous injection of Salbutamol. Secondary study objectives will explore the feasibility of conducting a larger, phase III trial. DISCUSSION: The trial will provide important information about the efficacy of salbutamol as an analgesic adjunct in renal colic. It will also guide the development of a definitive phase III trial to test the cost and clinical effectiveness of salbutamol as an analgesic adjunct in renal colic. Salbutamol benefits from widespread use across the health service for multiple indications, extensive staff familiarity and a good side effect profile; therefore, its potential use for pain relief may have significant benefits for patient care. TRIAL REGISTRATION: ISRCTN Registry ISRCTN14552440. Registered on 22 July 2019 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06225-9. |
format | Online Article Text |
id | pubmed-9036510 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-90365102022-04-25 Salbutamol for analgesia in renal colic: study protocol for a prospective, randomised, placebo-controlled phase II trial (SARC) Johnson, Graham Tabner, Andrew Fakis, Apostolos Sherman, Rachelle Chester, Victoria Bedford, Elizabeth Jackson, Richard Ratan, Hari Mason, Suzanne Trials Study Protocol BACKGROUND: Renal colic is the pain experienced by a patient when a renal calculus (kidney stone) causes partial or complete obstruction of part of the renal outflow tract. The standard analgesic regimes for renal colic are often ineffective; in some studies, less than half of patients achieve complete pain relief, and a large proportion of patients require rescue analgesia within 4 h. Current analgesic regimes are also associated with significant side effects including nausea, vomiting, drowsiness and respiratory depression. It has been hypothesised that beta adrenoreceptor agonists, such as salbutamol, may reduce the pain of renal colic. They have been shown to impact a number of factors that target the physiological causes of pain in renal colic (ureteric spasm and increased peristalsis, increased pressure at the renal pelvis and prostaglandin release with inflammation). There is biological plausibility and a body of evidence sufficient to suggest that this novel treatment for the pain of renal colic should be taken to a phase II clinical trial. The aim of this trial is to test whether salbutamol is an efficacious analgesic adjunct when added to the standard analgesic regime for patients presenting to the ED with subsequently confirmed renal colic. METHODS: A phase II, randomised, placebo-controlled trial will be performed in an acute NHS Trust in the East Midlands. Patients presenting to the emergency department with pain requiring IV analgesia and working diagnosis of renal colic will be randomised to receive standard analgesia ± a single intravenous injection of Salbutamol. Secondary study objectives will explore the feasibility of conducting a larger, phase III trial. DISCUSSION: The trial will provide important information about the efficacy of salbutamol as an analgesic adjunct in renal colic. It will also guide the development of a definitive phase III trial to test the cost and clinical effectiveness of salbutamol as an analgesic adjunct in renal colic. Salbutamol benefits from widespread use across the health service for multiple indications, extensive staff familiarity and a good side effect profile; therefore, its potential use for pain relief may have significant benefits for patient care. TRIAL REGISTRATION: ISRCTN Registry ISRCTN14552440. Registered on 22 July 2019 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06225-9. BioMed Central 2022-04-25 /pmc/articles/PMC9036510/ /pubmed/35468847 http://dx.doi.org/10.1186/s13063-022-06225-9 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Johnson, Graham Tabner, Andrew Fakis, Apostolos Sherman, Rachelle Chester, Victoria Bedford, Elizabeth Jackson, Richard Ratan, Hari Mason, Suzanne Salbutamol for analgesia in renal colic: study protocol for a prospective, randomised, placebo-controlled phase II trial (SARC) |
title | Salbutamol for analgesia in renal colic: study protocol for a prospective, randomised, placebo-controlled phase II trial (SARC) |
title_full | Salbutamol for analgesia in renal colic: study protocol for a prospective, randomised, placebo-controlled phase II trial (SARC) |
title_fullStr | Salbutamol for analgesia in renal colic: study protocol for a prospective, randomised, placebo-controlled phase II trial (SARC) |
title_full_unstemmed | Salbutamol for analgesia in renal colic: study protocol for a prospective, randomised, placebo-controlled phase II trial (SARC) |
title_short | Salbutamol for analgesia in renal colic: study protocol for a prospective, randomised, placebo-controlled phase II trial (SARC) |
title_sort | salbutamol for analgesia in renal colic: study protocol for a prospective, randomised, placebo-controlled phase ii trial (sarc) |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9036510/ https://www.ncbi.nlm.nih.gov/pubmed/35468847 http://dx.doi.org/10.1186/s13063-022-06225-9 |
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