A randomised controlled trial of interventions to reduce the pain and distress of nasogastric tube insertion in young children.

The primary objective of this study is to determine the effectiveness of: (1) topical intranasal lidocaine (3 mg/kg) and usual care, (2) intranasal midazolam (0.3 mg/kg) & topical intranasal lidocaine (3 mg/kg) and usual care, (3) intranasal fentanyl (1.5 mcg/kg) and topical intranasal lidocaine (3 mg/kg) and (4) usual care, and usual care only for reducing the occurrence of severe distress (score of 7 or more on the FLACC or r-FLACC scale) associated with nasogastric (NG) tube insertion in children aged six months to less than five years (4 years + 364 days). The registered nurses (RNs) working in the emergency department will administer the intervention medications. All RNs are trained and competent in administering intranasal (IN) medications to paediatric patients. Additionally, the administration of intranasal (IN) medications is a common practice in emergency departments Dosing, administration and timing of IN medications: All medication doses are based on the patient's weight. Each patient will be weighed according to the local policy for paediatric patients. Intranasal midazolam: The commercially available intravenous preparation of midazolam will be administered intranasally 15 minutes before the procedure at a dose of 0.3 mg/kg to a maximum of 10 mg using site specific supplies (e.g. Mucosal Atomiser DeviceTM) provided for intranasal administration split between nostrils. No alterations to the dose or top-up doses are allowed for study participants. For this study, an acceptable time deviation for the medication will be: 5 minutes before and 10 minutes after. Therefore, it will be in protocol if the NGT is inserted between 10 minutes and 25 minutes from when IN Midazolam is administered. Outside this window will be a protocol deviation. Intranasal fentanyl: Fentanyl will be administered intranasally using the commercially available intravenous preparation at a concentration of 100 micrograms / 2 mL using site specific supplies (e.g. Mucosal Atomiser DeviceTM) provided for intranasal administration split between nostrils. For consistency across intervention arms this will be administered 15 minutes before the procedure at a dose of 1.5 micrograms/kg (maximum dose 75 micrograms, noting that most children in the current study will have a considerably lower dose than this). Site-specific devices will be used for intranasal delivery. For this study, an acceptable time deviation: 5 minutes before and 10 minutes after. Therefore: It will be in protocol if the NGT is inserted between 10 minutes and 25 minutes from when IN Fentanyl is administered. Outside this window will be a protocol deviation. Topical lidocaine: Lidocaine is commercially available in 10% concentration with a metered dose spray nozzle. Each 100 microlitre metered dose delivers 10 mg of lidocaine. The recommended maximum dose in children is 3 mg/kg. Weight-based doses will be used and will be administered split between nostrils 5 minutes before the procedure. If an odd number of sprays is to be used, then the “extra” spray will be administered to the nostril deemed to most patent (judged by the clinician who is to insert the NG tube). When administering the intranasal medications to study participants, the dose will be split between both nostrils to avoid medication running down the back of the nasopharynx and being swallowed. Control: Usual Care Clinicians will provide usual care based on local policies and clinical practice guidelines. Typically, standard practice is to lubricate the NG tube with water or a water-based lubricant, or, in neonates use their own saliva. Young infants (under 12 months of age) may also be given 2 mL aliquots of 33% sucrose/glucose syrup immediately prior to the insertion attempt. The ‘usual care’ administered to each study participant will be documented on the case report form (CRF). Children randomised to usual care will not be administered any lidocaine, fentanyl, midazolam or other sedation / analgesia. The trial medications will be prescribed by the treating clinician according to the random allocation for the participant, and this prescription will be documented in the patient’s medical record at each site according to site-specific usual practice. Hospital medication records will be able to be viewed by the study team to ascertain the dose of intervention medications prescribed, and what was given. All Registered Nurses working in the participating departments are competent and familiar with administering IN medications to children.

Primary objectives To compare the effectiveness of the following interventions: (1) Topical intranasal lidocaine and usual care, (2) Intranasal midazolam, topical intranasal lidocaine and usual care, and (3) usual care alone for reducing the occurrence of severe distress (score of =7 or more on the FLACC or r-FLACC scale) during first attempt of nasogastric (NG) tube insertion in children aged six months to less than five years (4 years + 364 days) [cohort 1+2]. To compare the effectiveness of (1) Intranasal fentanyl, topical intranasal lidocaine and usual care (2) usual care alone for reducing the occurrence of severe distress (score of =7 or more on the FLACC or r-FLACC scale) during first attempt of nasogastric (NG) tube insertion in children aged 12 months to less than five years (4 years + 364 days) [cohort 2 only]. The registered nurses (RNs) working in the emergency department will administer the intervention medications. All RNs are trained and competent in administering intranasal (IN) medications to paediatric patients. Additionally, the administration of intranasal (IN) medications is a common practice in emergency departments Dosing, administration and timing of IN medications: All medication doses are based on the patient's weight. Each patient will be weighed according to the local policy for paediatric patients. Intranasal midazolam: The commercially available intravenous preparation of midazolam will be administered intranasally 15 minutes before the procedure at a dose of 0.3 mg/kg to a maximum of 10 mg using site specific supplies (e.g. Mucosal Atomiser DeviceTM) provided for intranasal administration split between nostrils. No alterations to the dose or top-up doses are allowed for study participants. For this study, an acceptable time deviation for the medication will be: 5 minutes before and 10 minutes after. Therefore, it will be in protocol if the NGT is inserted between 10 minutes and 25 minutes from when IN Midazolam is administered. Outside this window will be a protocol deviation. Intranasal fentanyl: (Only for 12months to 5 years). Fentanyl will be administered intranasally using the commercially available intravenous preparation at a concentration of 100 micrograms / 2 mL using site specific supplies (e.g. Mucosal Atomiser DeviceTM) provided for intranasal administration split between nostrils. For consistency across intervention arms this will be administered 15 minutes before the procedure at a dose of 1.5 micrograms/kg (maximum dose 75 micrograms, noting that most children in the current study will have a considerably lower dose than this). Site-specific devices will be used for intranasal delivery. For this study, an acceptable time deviation: 5 minutes before and 10 minutes after. Therefore: It will be in protocol if the NGT is inserted between 10 minutes and 25 minutes from when IN Fentanyl is administered. Outside this window will be a protocol deviation. Topical lidocaine: Lidocaine is commercially available in 10% concentration with a metered dose spray nozzle. Each 100 microlitre metered dose delivers 10 mg of lidocaine. The recommended maximum dose in children is 3 mg/kg. Weight-based doses will be used and will be administered split between nostrils 5 minutes before the procedure. If an odd number of sprays is to be used, then the “extra” spray will be administered to the nostril deemed to most patent (judged by the clinician who is to insert the NG tube). When administering the intranasal medications to study participants, the dose will be split between both nostrils to avoid medication running down the back of the nasopharynx and being swallowed. Control: Usual Care Clinicians will provide usual care based on local policies and clinical practice guidelines. Typically, standard practice is to lubricate the NG tube with water or a water-based lubricant, or, in neonates use their own saliva. Young infants (under 12 months of age) may also be given 2 mL aliquots of 33% sucrose/glucose syrup immediately prior to the insertion attempt. The ‘usual care’ administered to each study participant will be documented on the case report form (CRF). Children randomised to usual care will not be administered any lidocaine, fentanyl, midazolam or other sedation / analgesia. The trial medications will be prescribed by the treating clinician according to the random allocation for the participant, and this prescription will be documented in the patient’s medical record at each site according to site-specific usual practice. Hospital medication records will be able to be viewed by the study team to ascertain the dose of intervention medications prescribed, and what was given. All Registered Nurses working in the participating departments are competent and familiar with administering IN medications to children.