Lignocaine/phenylephrine nasal spray vs. placebo for the pain and distress of nasogastric tube insertion in children: a study protocol for a randomized controlled trial

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Abstract

BACKGROUND: Patients and clinicians consistently rate insertion of a nasogastric tube (NGT) as one of the most painful and distressing emergency department procedures. Despite this, surveys of emergency clinicians suggest that provision of adequate procedural analgesia is often inconsistent and suboptimal. While many studies have demonstrated the effectiveness of various interventions to reduce pain and distress in adults, there have been few studies in the pediatric population. There are currently no studies comparing the effectiveness of a local anesthetic nasal spray for the prevention of the pain and distress associated with NGT insertion in children. This study aims to compare the analgesic efficacy of a proprietary preparation of lignocaine/phenylephrine nasal spray and placebo for this indication. METHODS/DESIGN: This is a prospective, randomized, controlled, double-blind superiority trial of 100 children aged 6 months to 5 years weighing at least 6 kg in whom a nasogastric tube is planned to be inserted. These children will be randomized to either intranasal lignocaine/phenylephrine or placebo. Pain severity is the primary outcome measure and will be measured utilizing the Face, Legs, Arms, Cry and Consolability (FLACC) pain severity rating scale. An independent staff member not involved in inserting the NGT and the child s parents or carer will also record pain and distress on a visual analog scale (VAS). FLACC scores and VAS scores will be presented as median and interquartile range (IQR). Non-normally distributed scores will be compared using a Wilcoxon rank-sum test. Categorical data will be analyzed using Fisher s exact test. Adverse events will be described as type and incidence. DISCUSSION: Previous studies on NGT insertion have not focused on the pediatric population. This study aims to establish the effectiveness of a simple intranasal spray of lignocaine/phenylephrine in children undergoing NGT insertion. A positive result of this study would provide evidence of an effective intervention in a procedure considered by many to be very painful and distressing. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR). ACTRN12614000092695 , registered on 23 January 2014.
Original languageEnglish
Pages (from-to)e30 - e30
Number of pages5
JournalTrials
Volume16
DOIs
Publication statusPublished - 2015

Cite this

@article{5b59d64d23d64883aed0f0e09245278b,
title = "Lignocaine/phenylephrine nasal spray vs. placebo for the pain and distress of nasogastric tube insertion in children: a study protocol for a randomized controlled trial",
abstract = "BACKGROUND: Patients and clinicians consistently rate insertion of a nasogastric tube (NGT) as one of the most painful and distressing emergency department procedures. Despite this, surveys of emergency clinicians suggest that provision of adequate procedural analgesia is often inconsistent and suboptimal. While many studies have demonstrated the effectiveness of various interventions to reduce pain and distress in adults, there have been few studies in the pediatric population. There are currently no studies comparing the effectiveness of a local anesthetic nasal spray for the prevention of the pain and distress associated with NGT insertion in children. This study aims to compare the analgesic efficacy of a proprietary preparation of lignocaine/phenylephrine nasal spray and placebo for this indication. METHODS/DESIGN: This is a prospective, randomized, controlled, double-blind superiority trial of 100 children aged 6 months to 5 years weighing at least 6 kg in whom a nasogastric tube is planned to be inserted. These children will be randomized to either intranasal lignocaine/phenylephrine or placebo. Pain severity is the primary outcome measure and will be measured utilizing the Face, Legs, Arms, Cry and Consolability (FLACC) pain severity rating scale. An independent staff member not involved in inserting the NGT and the child s parents or carer will also record pain and distress on a visual analog scale (VAS). FLACC scores and VAS scores will be presented as median and interquartile range (IQR). Non-normally distributed scores will be compared using a Wilcoxon rank-sum test. Categorical data will be analyzed using Fisher s exact test. Adverse events will be described as type and incidence. DISCUSSION: Previous studies on NGT insertion have not focused on the pediatric population. This study aims to establish the effectiveness of a simple intranasal spray of lignocaine/phenylephrine in children undergoing NGT insertion. A positive result of this study would provide evidence of an effective intervention in a procedure considered by many to be very painful and distressing. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR). ACTRN12614000092695 , registered on 23 January 2014.",
author = "Craig, {Simon Stuart} and Robert Seith and Cheek, {John A} and West, {Adam Lawrence} and Kathryn Wilson and Diana Egerton-Warburton",
year = "2015",
doi = "10.1186/s13063-015-0547-y",
language = "English",
volume = "16",
pages = "e30 -- e30",
journal = "Trials",
issn = "1745-6215",
publisher = "Springer-Verlag London Ltd.",

}

TY - JOUR

T1 - Lignocaine/phenylephrine nasal spray vs. placebo for the pain and distress of nasogastric tube insertion in children: a study protocol for a randomized controlled trial

AU - Craig, Simon Stuart

AU - Seith, Robert

AU - Cheek, John A

AU - West, Adam Lawrence

AU - Wilson, Kathryn

AU - Egerton-Warburton, Diana

PY - 2015

Y1 - 2015

N2 - BACKGROUND: Patients and clinicians consistently rate insertion of a nasogastric tube (NGT) as one of the most painful and distressing emergency department procedures. Despite this, surveys of emergency clinicians suggest that provision of adequate procedural analgesia is often inconsistent and suboptimal. While many studies have demonstrated the effectiveness of various interventions to reduce pain and distress in adults, there have been few studies in the pediatric population. There are currently no studies comparing the effectiveness of a local anesthetic nasal spray for the prevention of the pain and distress associated with NGT insertion in children. This study aims to compare the analgesic efficacy of a proprietary preparation of lignocaine/phenylephrine nasal spray and placebo for this indication. METHODS/DESIGN: This is a prospective, randomized, controlled, double-blind superiority trial of 100 children aged 6 months to 5 years weighing at least 6 kg in whom a nasogastric tube is planned to be inserted. These children will be randomized to either intranasal lignocaine/phenylephrine or placebo. Pain severity is the primary outcome measure and will be measured utilizing the Face, Legs, Arms, Cry and Consolability (FLACC) pain severity rating scale. An independent staff member not involved in inserting the NGT and the child s parents or carer will also record pain and distress on a visual analog scale (VAS). FLACC scores and VAS scores will be presented as median and interquartile range (IQR). Non-normally distributed scores will be compared using a Wilcoxon rank-sum test. Categorical data will be analyzed using Fisher s exact test. Adverse events will be described as type and incidence. DISCUSSION: Previous studies on NGT insertion have not focused on the pediatric population. This study aims to establish the effectiveness of a simple intranasal spray of lignocaine/phenylephrine in children undergoing NGT insertion. A positive result of this study would provide evidence of an effective intervention in a procedure considered by many to be very painful and distressing. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR). ACTRN12614000092695 , registered on 23 January 2014.

AB - BACKGROUND: Patients and clinicians consistently rate insertion of a nasogastric tube (NGT) as one of the most painful and distressing emergency department procedures. Despite this, surveys of emergency clinicians suggest that provision of adequate procedural analgesia is often inconsistent and suboptimal. While many studies have demonstrated the effectiveness of various interventions to reduce pain and distress in adults, there have been few studies in the pediatric population. There are currently no studies comparing the effectiveness of a local anesthetic nasal spray for the prevention of the pain and distress associated with NGT insertion in children. This study aims to compare the analgesic efficacy of a proprietary preparation of lignocaine/phenylephrine nasal spray and placebo for this indication. METHODS/DESIGN: This is a prospective, randomized, controlled, double-blind superiority trial of 100 children aged 6 months to 5 years weighing at least 6 kg in whom a nasogastric tube is planned to be inserted. These children will be randomized to either intranasal lignocaine/phenylephrine or placebo. Pain severity is the primary outcome measure and will be measured utilizing the Face, Legs, Arms, Cry and Consolability (FLACC) pain severity rating scale. An independent staff member not involved in inserting the NGT and the child s parents or carer will also record pain and distress on a visual analog scale (VAS). FLACC scores and VAS scores will be presented as median and interquartile range (IQR). Non-normally distributed scores will be compared using a Wilcoxon rank-sum test. Categorical data will be analyzed using Fisher s exact test. Adverse events will be described as type and incidence. DISCUSSION: Previous studies on NGT insertion have not focused on the pediatric population. This study aims to establish the effectiveness of a simple intranasal spray of lignocaine/phenylephrine in children undergoing NGT insertion. A positive result of this study would provide evidence of an effective intervention in a procedure considered by many to be very painful and distressing. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR). ACTRN12614000092695 , registered on 23 January 2014.

UR - http://www.ncbi.nlm.nih.gov/pubmed/25622681

U2 - 10.1186/s13063-015-0547-y

DO - 10.1186/s13063-015-0547-y

M3 - Article

VL - 16

SP - e30 - e30

JO - Trials

JF - Trials

SN - 1745-6215

ER -