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

Phase 4

Completed

• Conditions: Distress associated with insertion of nasogastric tube in children (aged 6 months-5 years); Public Health - Health service research

• Registration Number: ACTRN12614000092695
• Lead Sponsor: Dr Simon Craig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Children who are (1) aged 6 months to 5 years of age AND (2) weigh at least 6kg who are due to have a nasogastric tube inserted as part of their emergency department treatment.

Exclusion Criteria

*Inability to gain informed consent from parent or guardian
*Indication for an urgent insertion of a nasogastric tube
*Accompanying adult is non-English speaking and no interpreter service is available
*Child or parent has an allergy to lignocaine or phenylephrine
*Aberrant nasal anatomy
*Acute or chronic nasal problems or nasal trauma that may preclude adequate administration or absorption of intranasal medication.
*Cardiovascular disease / congenital heart disease – specifically hypertension, severe bradycardia, conduction disturbances and digitalis intoxication
*Known hepatic or renal impairment
*Asthma (particularly sulfite-sensitive asthma)
*Genetic predisposition to malignant hyperthermiaPre-existing abnormal neurological conditions
*Child is taking medications known to interact with Co-phenylcaine Forte (Antiarrhythmic drugs;Suxamethonium; Phenytoin;Antidepressants; Propranolol;)Citicoline

Study & Design

• Study Type: Interventional
• Study Design: Not specified