None listed
Conditions
Brief summary
This study is designed to determine the safety and efficacy of non-operative antibiotic management of clinically diagnosed acute uncomplicated appendicitis in children. Enrolled patients will be randomised and an allocation ratio of 1:1 will be made via weighted minimisation, where half of the patients will receive non-operative management with intravenous Piperacillin with Tazobactam, while the other half will have an appendicectomy.
Interventions
Non-operative management group (NOM) Children in the NOM group will receive intravenous Piperacillin with Tazobactam (Tazocin) 100mg/kg/ dose every 8 hours for at least 24 hours, and they will be observed and reassessed within 24 hours after randomisation. A further 24 hours of intravenous Piperacillin with Tazobactam therapy will be offered to children in invariable condition. A clinical decision will be made by the attending surgeon to offer operative management if a patient’s condition deteri
Non-operative management group (NOM) Children in the NOM group will receive intravenous Piperacillin with Tazobactam (Tazocin) 100mg/kg/ dose every 8 hours for at least 24 hours, and they will be observed and reassessed within 24 hours after randomisation. A further 24 hours of intravenous Piperacillin with Tazobactam therapy will be offered to children in invariable condition. A clinical decision will be made by the attending surgeon to offer operative management if a patient’s condition deteriorates at any time, or if a patient has failed to improve after 48 hours of intravenous antibiotic therapy. Once the patient is clinically improving and tolerating oral intake, the antibiotic regimen will be changed to oral Amoxicillin plus Clavulanic acid (Augmentin) 22.5mg/kg/dose twice per day to complete a total seven day course of antibiotics. Oral Ciprofloxacin 15mg/kg/dose twice daily and oral Metronidazole 10mg/kg/dose twice daily will be offered to children who are known to have an intolerance or allergy to Amoxicillin or Clavulanic acid.
Sponsors
The Sydney Children's Hospital Network
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 5 and 16 years; 2. Clinical diagnosis by at least one paediatric surgeon (or duty surgical registrar) of acute uncomplicated appendicitis based on with a combination of clinical, laboratory and/or imaging findings; that before the study would have led to the decision to recommend been subjected to an appendicectomy.
Exclusion criteria
If one or more of the following is assessed to be present: 1. Suspicion of perforated appendicitis on the basis of generalised peritonitis and/ or imaging studyA diagnosis of perforated or complicated appendicitis (e.g. peritonitis, appendiceal mass) is made on the basis of clinical, laboratory and/or imaging findings; 2. Previous non-operative treatment of acute appendicitis; 3. Age younger than 5 years or older than 16 years; 4. Known intolerance or allergy to Piperacillin with Tazobactam; 5. Known history of inflammatory bowel disease, or other chronic abdominal pain syndrome; 6. Known concurrent significant illness; 7. Unable to obtain informed consent from parents or guardian; 8. Known to have a cognitive impairment, an intellectual disability or a mental illness that would impair participation.
Outcome results
None listed