None listed
Conditions
Brief summary
STOP is intended to be a small pilot study conducted in a specialised paediatric emergency department (ED) examining the effect of giving the medication tranexamic acid or 'TXA' via a nebuliser on children aged 3-16y ears who come to the ED with throat bleeding after tonsillectomy surgery. We intend to study whether nebulised TXA is a safe and effective alternative to intravenous TXA, which is currently part of the standard treatment for this condition in the institution involved. Each child presenting to our ED with bleeding following tonsillectomy surgery will be screened for suitability, considered for enrolment and approached for consent to participate. Half of the patients will be allocated to a single initial dose of nebulised TXA and half will be allocated the standard single dose intravenous TXA treatment. We will grade the severity of bleeding from the throat on each patient firstly on their arrival to the ED and again 15 minutes after the TXA has been administered. We will also capture data concerning the timing of treatment, the acceptability and tolerance to nebulised TXA for this condition and information regarding the patient's episode of hospital care. The results will help us understand whether nebulised TXA is tolerated, easy to administer, its safety profile and its impact on post tonsillectomy bleeding in comparison to IV TXA treatment. We will also seek to establish if there is any evident differences in subsequent hospital stay and medium term adverse effects.
Interventions
A single dose of nebulised tranexamic acid (nTXA) for patients (aged 3-16 yrs) presenting to the emergency department (ED) with a case of secondary post tonsillectomy haemorrhage (sPTH). The solution for injection form of tranexamic acid (100mg/ml) will be used and administered via a nebuliser. The dose will be 250 mg for patients weighing less than or equal to 25 kg and 500 mg for patients weighing more than 25 kg. The nebulised dose of TXA will be given in lieu of a single intravenous dose of
A single dose of nebulised tranexamic acid (nTXA) for patients (aged 3-16 yrs) presenting to the emergency department (ED) with a case of secondary post tonsillectomy haemorrhage (sPTH). The solution for injection form of tranexamic acid (100mg/ml) will be used and administered via a nebuliser. The dose will be 250 mg for patients weighing less than or equal to 25 kg and 500 mg for patients weighing more than 25 kg. The nebulised dose of TXA will be given in lieu of a single intravenous dose of TXA which is our current standard management for sPTH in the ED at the study site. Adherence to the intervention will monitored in a number of ways. The allocated study pack will be bundled with the study data collection form (CF). This will provide clear guidance on which form of TXA is to be given and will provide a source of documentation. Medical records including ED medical notes, ED nursing notes and medication charts will also provide sources to verify method and dose of TXA administration.
Sponsors
Perth Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
3 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
Patients age 3-16 years presenting to a tertiary paediatric emergency department within the hours of 0600-2400 with secondary post tonsillectomy haemorrhage (sPTH). sPTH is defined as bleeding onset more than 24hrs after initial tonsillectomy.
Exclusion criteria
Initial Exclusion Criteria; Any sPTH patient with an obvious Grade 4 bleed. Any sPTH patient that appears pale, subdued or unwell looking. Any sPTH patient with a HR or BP giving an early warning score of 3 on the local institution's Paediatric Acute Recognition and Response Observation Tool at the time of ED presentation. Further Exclusion Criteria; Any patient presenting with sPTH who has already received IV TXA or oral TXA as part of their treatment for that episode of sPTH. This may occur if they have transferred from a peripheral ED. Patients with a known allergy or contraindication to TXA. Patients with a history of severe asthma defined as previous ICU admission for asthma. Patients with a prothrombotic condition including thromboembolism, deep venous thrombosis, stroke, or Kawasaki’s disease. Patients with known renal impairment. Patients with a seizure disorder Patients with a known bleeding disorder Patients who have previously been enrolled in this study Patients with parents or carers who are judged to have a limited understanding of English and therefore, will not be able to participate in the deferred consent process.
Outcome results
None listed