Appendicitis
Conditions
Brief summary
The objective of this study is to determine whether administering once-daily doses of metronidazole, an intravenous (IV) antibiotic used to prevent infection in perforated appendicitis, is as effective in children as delivering it in the standard method of once every eight hours. Reducing the frequency of administration has the potential of decreasing personnel time and healthcare cost and increasing the lifespan of the IV line. To determine the effectiveness once-daily administration, a randomized controlled trial (RCT) will be conducted to compare outcomes between the two treatment schedules. We will recruit 100 patients (50 per treatment) aged 5-18 being surgically treated for perforated appendicitis at the Children's Hospital of Eastern Ontario, who will be randomly assigned to one of the two treatment schedules. To compare the efficacy of the treatments, outcomes such as duration of hospital stay and theoretical cost will be measured and analyzed using statistical tests.
Interventions
DRUGMetronidazole
Administration once daily
Sponsors
Ahmed Nasr
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* All children 5-18 years of age, presenting to CHEO with perforated appendicitis (confirmed either in the operating room or diagnosed preoperatively according to radiological criteria), and managed surgically will be assessed for eligibility to participate. These patients may participate if baseline lab values of serum AST (SGOT), AL T (SGPT), LDH, triglycerides and hexokinase glucose are normal, complete physical exam is normal, hGC test is negative for pregnancy (if the patient is a female of reproductive age) and none of the
Exclusion criteria
are present.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | until discharge (usually less than one week after admission) | • Duration of hospital stay (in days) during initial admission for perforated appendicitis (Patient will be discharged when eating normal diet, afebrile for 24 hours and no abdominal pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of narcotics | From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first. | mg/kg per day of narcotics |
| Duration of narcotics | From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first. | total number of days of narcotics |
| Failure of antibiotics | during hospital stay (usually less than one week) | o No clinical improvement after five days, as decided by the patient's surgeon. This will result in the patient being switched to a regimen of different antibiotics. |
| Duration of antibiotics oral | From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first. | duration of oral antibiotic therapy following discharge (days) |
| Theoretical cost in CAD | From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first. | In our study, due to blinding, much of the potential cost-savings of once-daily administration of metronidazole - including nursing time, pharmacy time, and IV materials - will not be evident. However, we will calculate the potential cost-savings of once-daily administration. This will be based on number of hours of nursing time saved (the research coordinator (RC) will, on 10 occasions, observe a nurse administering a dose of metronidazole to a patient not enrolled in this study, and will average these to estimate the time required to administer one dose), number of hours of pharmacy time saved (the RC will, on 10 occasions, observe a pharmacist preparing a dose of metronidazole for a patient not enrolled in this study, and will average these to estimate the time required to prepare one dose), and cost saved on materials (the minibag used to deliver the antibiotic, the IV needle and line if it needed to be replaced, etc.) |
| Duration of antibiotics IV | From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first. | duration of IV antibiotic therapy (days) |
Outcome results
None listed