A randomised double-blind controlled trial of lignocaine/phenylephrine nasal spray vs placebo for pain and distress of nasogastric tube insertion in children

Study drugs Intranasal lignocaine / phenylephrine spray is available proprietary product which contains the active ingredients of lignocaine hydrochloride 50 mg/mL and phenylephrine hydrochloride 5 mg/mL. It is administered by a pump actuated topical spray. The nozzle spray attachment provides 100 micolitres per spray. This results in each spray providing 5mg lignocaine and 0.5mg phenylephrine. Placebo spray (0.9% sodium chloride) Prepared and packaged in an identical manner to study drug (lignocaine / phenylephrine) Dosing schedule for blinded administration of intranasal lignocaine / phenylephrine or saline placebo.(1, 2) * 6 kg – 12 kg 1 spray per nostril * >12 kg 2 sprays per nostril Medication preparation, storage and use-monitoring Spray bottles will be prepared and checked in a clean area by manufacturing service pharmacists in the pharmacy department at MMC Clayton. Lignocaine / phenylephrine spray bottles will be made by transferring 2.5mL of CoPhenylcaine Forte into a spray bottle. This will then be labelled and kept in a sealed plastic bag until use. Placebo spray bottles will be made by transferring 2.5mL of sodium chloride 0.9% for irrigation into a spray bottle. This will again be labelled and kept in a sealed plastic bag until use. Spray bottle numbers, constituents, their batch number, expiry will be recorded by sterile manufacturing and clinical trials pharmacy. A prescription marked with the corresponding spray bottle number will be included in each bag - for return to pharmacy for study accountability. The study spray bottles will be given an expiry of one month from manufacture. Twenty spray bottles will be prepared monthly by pharmacy. Each month unused spray bottles will be deemed expired and destroyed by pharmacy. Spray bottle numbers not used will be documented and later re-made (with the same allocation) until all 100 spray bottle numbers are accounted for. If recruitment of patients is in excess of 5 per week, spray bottle number production will be reviewed and may increase up to a maximum of eight per week. Labelling In order to avoid administration errors in the emergency department, the drug will be prominently labelled with “Not for injection, for intranasal use only.” Each spray bottle and outer bag will be labelled with the spray bottle number and instructions for dose and usage as follows: CoPhenylcaine (lignocaine 5mg/spray and phenylephrine 0.5mg/spray) OR Placebo (0.9% sodium chloride solution) [MMC project no: XXXXXX] 2.5mL Administer spray from study weight / dose table, using supplied spray bottle and nozzle. Spray bottle no:.............. Batch:.............................. Expiry:...................... Storage CoPhenylcaine is a Schedule 2 (S2) medication. As such, the study medication will be stored in a locked drug room in the paediatric emergency department. Prescriptions will include the study drug and number of sprays to be administered. Refrences 1. Lignocaine. Australian Medicines Handbook 2013 (Online). Adelaide: Australian Medicines Handbook Pty Ltd; 2013. 2. CoPhenylcaine Forte Mims Online [Internet]. St Leonards, NSW: UBM Medica; 2013.