Inaccurate diagnosis of paediatric anaphylaxis in three Australian Emergency Departments.

AIM: To determine the accuracy of emergency department (ED) paediatric anaphylaxis diagnosis, and to identify factors associated with misdiagnosis. METHODS: Retrospective chart review of children aged 0-18 years with allergic presentations to three Victorian EDs in 2014. Cases were included if an ED diagnosis of anaphylaxis was recorded, or the presentation met international consensus criteria for anaphylaxis. RESULTS: Of the 60 143 paediatric ED presentations during the study period, 1551 allergy-related presentations were identified and reviewed. One hundred and eighty-seven met consensus criteria for anaphylaxis, and another 24 were diagnosed with anaphylaxis without meeting criteria. Of the 211 presentations, 105 cases were given an ED diagnosis of anaphylaxis and 106 cases were given an alternative diagnosis in ED. ED assessment had a sensitivity of 43.2% (95% confidence interval (CI) 36.1-50.7%) and specificity of 97.9% (95% CI 96.9-98.7%) for anaphylaxis. Multiple logistic regression demonstrated that an ED anaphylaxis diagnosis was associated with previous anaphylaxis (odds ratio (OR) 3.20; 95% CI 1.52-6.75), arrival by ambulance (OR 2.80; 95% CI 1.36-5.74), a high-acuity triage category (OR 4.51; 95% CI 2.20-9.25) and presentation to a tertiary hospital (OR 2.86; 95% CI 1.44-5.67). ED diagnosis of anaphylaxis was less likely in those with resolution of symptoms and signs in at least one organ system prior to arrival (OR 0.27; 95% CI 0.12-0.62). CONCLUSION: In children with allergic presentations, ED assessment has a low sensitivity but high specificity for anaphylaxis. Attention to resolved pre-hospital symptoms and awareness of diagnostic criteria are important considerations for accurate ED diagnosis of anaphylaxis.

The PICHFORK (Pain in Children Fentanyl or Ketamine) trial: a randomized controlled trial comparing intranasal ketamine and fentanyl for the relief of moderate to severe pain in children with limb injuries.

STUDY OBJECTIVE: We compare the analgesic effectiveness of intranasal fentanyl and ketamine in children. METHODS: This was a double-blind, randomized, controlled trial comparing fentanyl at 1.5 µg/kg with ketamine at 1 mg/kg in children aged 3 to 13 years and weighing less than 50 kg, with isolated limb injury and pain of more than 6 of 10 at triage. The sample size was 40 in each arm. Subjects were coadministered oral ibuprofen at 10 mg/kg. The primary outcome was median pain rating reduction at 30 minutes. Secondary outcomes were pain rating reduction at 15 and 60 minutes, subjective improvement and satisfaction, University of Michigan Sedation Score, adverse events, and rescue analgesia. RESULTS: Eighty children enrolled, and 73 were available for analysis: 37 fentanyl and 36 ketamine. Median age was 8 years; 63% were male children; median baseline pain rating was 80 mm. At 30 minutes, median reductions for ketamine and fentanyl were 45 and 40 mm, respectively (difference 5 mm; 95% confidence interval [CI] -10 to 20 mm). Reductions exceeded 20 mm for ketamine and fentanyl in 82% and 79% of patients, respectively (difference 3%; 95% CI -22% to 16%). Pain rating reduction was maintained to 60 minutes in both groups. Satisfaction was reported for ketamine and fentanyl by 83% and 72% of patients, respectively (difference 11%; 95% CI -9% to 30%). Adverse events, mainly mild, were reported for ketamine and fentanyl by 78% and 40% of patients, respectively (difference 38%; 95% CI -58% to 16%). Three ketamine patients had a moderate degree of sedation by University of Michigan Sedation Score. CONCLUSION: Intranasal fentanyl and ketamine were associated with similar pain reduction in children with moderate to severe pain from limb injury. Ketamine was associated with more minor adverse events.

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.

The PICHFORK (Pain InCHildren Fentanyl OR Ketamine) trial comparing the efficacy of intranasal ketamine and fentanyl in the relief of moderate to severe pain in children with limb injuries: study protocol for a randomized controlled trial.

BACKGROUND: The effectiveness of intranasal (IN) fentanyl as an analgesic for painful pediatric limb injuries in the Emergency Department (ED) has been reported previously. However, efficacy of IN ketamine in sub-dissociative doses is not well studied in the ED setting. A non-blinded pilot study undertaken by this study group suggested that IN ketamine showed similar analgesic effectiveness to that reported with IN fentanyl in similar non-blinded studies. The aim of this randomized, controlled, equivalence trial is to compare the analgesic effect of sub-dissociative dose IN ketamine with IN fentanyl for children with isolated musculoskeletal limb injuries. METHODS/DESIGN: This is a prospective, randomized, controlled, double-blind equivalence trial of children agedthree to thirteen years and less than 50 kg body weight, with isolated musculoskeletal limb injury, presenting to the ED with moderate to severe pain, defined as a verbal response of at least six to a standard 11-point scale (0=none, 10=worst pain imaginable). Pain score, sedation, satisfaction with analgesic intervention, and adverse effects will be assessed over a 60 minute interval for each participant. Intranasal ketamine (1 mg/kg) or fentanyl (1.5 microgram/kg) will be administered via blinded syringe and mucosal atomization device in a standardized volume at 0.03 ml/kg, with a maximum volume of 1.5 ml divided equally to both nares. Participants will also receive 10 mg/kg ibuprofen orally. The primary outcome measure will be median change in pain score from pre-administration to 30 minutes post-administration. Non-parametric Mann-Whitney U tests will be computed to compare median change in the primary outcome measure for IN ketamine and fentanyl. A sample size of 36 participants per group is needed to detect the expected 40 mm reduction in pain rating with a 95% confidence interval (CI) no greater than ±10 mm at 30 minutes. Rescue analgesia will be given as IN fentanyl or intravenous morphine. DISCUSSION: This is the first randomized-controlled trial comparing the efficacy of these two analgesic agents via the intranasal route. If IN ketamine is found to be equally effective to IN fentanyl for this indication, it will provide another analgesic agent that may be considered for the relief of acute pain in children in the ED. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12612000795897.

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.