Lidocaine and phenylephrine versus saline placebo nasal spray for the pain and distress of nasogastric tube insertion in young children and infants: a randomised, double-blind, controlled trial.

BACKGROUND: Nasogastric tube insertion is a common but distressing procedure in young children. We aimed to compare the efficacy of topical local anaesthetic and vasoconstrictor nasal spray with placebo for distress related to nasogastric tube insertion. METHODS: We did a prospective, randomised, controlled, double-blind, superiority trial in a single tertiary paediatric emergency department in Australia. Eligible participants were children aged 6 months to 5 years who were planned to have a nasogastric tube inserted as part of their emergency department treatment. Patients were assigned using computer-generated block randomisation to receive lidocaine and phenylephrine nasal spray (10 mg lidocaine and 1 mg phenylephrine for children weighing 6-12 kg; 20 mg lidocaine and 2 mg phenylephrine for children weighing >12 kg), or 0·9% sodium chloride placebo nasal spray, before nasogastric insertion. Guardians, observers, and proceduralists were all masked to the intervention. The primary outcome was procedure-related distress, measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale during the final attempt at nasogastric tube insertion. All patients were included in the primary analysis (intention-to-treat). FLACC scores were compared using the Wilcoxon rank-sum test, and categorical outcomes were compared using χ2 or Fisher's exact tests as appropriate. This study is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12614000092695. FINDINGS: Between July 30, 2014, and Aug 17, 2017, 107 children in a convenience sample were randomly assigned to receive lidocaine and phenylephrine nasal spray (n=54) or placebo (n=53). Seven children did not receive study medication (six no longer required nasogastric tube insertion and one withdrew consent). 50 children received each intervention; all were included in the analysis. There was no difference in median FLACC score at time of nasogastric tube insertion (9 [IQR 7-10] for lidocaine and phenylephrine vs 9 [IQR 8-10] for placebo; median difference between groups -1, 95% CI -2·7 to 0·7, p=0·21). Adverse effects of the spray or nasogastric tube insertion (most commonly vomiting and gagging) occurred in 14 (28%) of those who received lidocaine and phenylephrine and 21 (42%) of those who received placebo. INTERPRETATION: Lidocaine and phenylephrine nasal spray does not reduce procedure-related distress associated with nasogastric tube insertion in young children compared with placebo. Further research addressing distress associated with nasogastric tube insertion in young children is needed. FUNDING: Monash Health Senior Medical Staff Association, Australasian College for Emergency Medicine, Emergency Medicine Research Foundation.

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.

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.

Intranasal fentanyl and high-concentration inhaled nitrous oxide for procedural sedation: a prospective observational pilot study of adverse events and depth of sedation.

OBJECTIVES: Nitrous oxide (N(2)O) is an attractive agent for pediatric procedural sedation and analgesia (PSA) with rapid onset and offset of sedation. However, it has limited analgesic efficacy. Intranasal fentanyl (INF) provides nonparenteral analgesia. There are currently no data on the combined use of N(2)O and INF for PSA in children. The authors set out to prospectively assess the depth of sedation and incidence of adverse events when N(2)O and INF are used in combination in pediatric patients. METHODS: This was a prospective observational pilot study of combined N(2)O and INF for PSA at a tertiary children's hospital emergency department (ED). INF was administered at a precalculated dose of 1.5 µg/kg for preascertained weight ranges. N(2)O concentration, dose, timing of INF, adverse events, and sedation depth were recorded. Sedation depth was recorded using the University of Michigan Sedation Scale (UMSS). RESULTS: A total of 41 patients, aged 1 to 14 years, received INF within 2 hours prior to N(2)O. N(2)O was administered at a maximal concentration of 70% in 40 patients, and at 50% in one patient. Most patients (80%) were minimally to moderately sedated (sedation score 1 or 2). Deep sedation (sedation score 3) was recorded in 14.6% of patients (95% confidence interval [CI] = 3.4% to 24.6%). No patients had serious adverse events; vomiting was recorded in 19.5% (95% CI = 7.4% to 31.6%). There were two patients (4.9%) who were deeply sedated and vomited during the procedure. CONCLUSIONS: There were no serious adverse events identified in this pilot study of combined N(2)O and INF. However, there was an increased incidence of vomiting and deeper levels of sedation when compared to published data of single-agent use of N(2)O, which could lead to more serious adverse events. Further investigation is needed to establish the analgesic efficacy of combining N(2)O and INF and to clarify the safety profile before this combination can be recommended for PSA in children.