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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| q8h | Active Comparator | Metronidazole given every 8 hours |
|
| q24h | Experimental | Metronidazole given once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole | Drug | Administration once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | • 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) | until discharge (usually less than one week after admission) |
| Measure | Description | Time Frame |
|---|---|---|
| Failure of antibiotics | 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. | during hospital stay (usually less than one week) |
| Quantity of narcotics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Nasr | CHEO | Principal Investigator |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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mg/kg per day of narcotics |
| From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first. |
| Duration of narcotics | total number of days of narcotics | From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first. |
| Duration of antibiotics IV | duration of IV antibiotic therapy (days) | From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first. |
| Duration of antibiotics oral | duration of oral antibiotic therapy following discharge (days) | From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first. |
| Theoretical cost in CAD | 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.) | From date of randomization to date of death from any cause or three months after initial discharge from hospital, whichever comes first. |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |