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| Name | Class |
|---|---|
| Monash Medical Centre | OTHER |
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Hypothesis: A single dose of prophylactic antibiotics is as effective as a three dose regime in preventing post-operative complications in paediatric patients with simple appendicitis.
This project will compare patients 16 years and under with simple appendicitis (appendicitis that is not perforated or gangrenous). Patients will be randomly divided into two groups;
Group allocation will be concealed from the patient and their guardian, the treating surgical team and outcome assessors (triple blinded). A process to rapidly reveal group allocation if required will be in place.
The aim of the study is to determine if a single dose of antibiotics is as effective as three doses in preventing post-operative infection. This will be assessed by comparing:
Information will be collected prospectively from each patient's hospital notes and from a follow-up phone call six weeks after the operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of antibiotics | Experimental | This group will receive one dose of IV metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g) in the pre-operative period and two post-operative IV 'doses' of normal saline 8 and 16 hours after the pre-operative dose, which will act as a placebo and facilitate blinding. |
|
| Three doses of antibiotics | Active Comparator | This group will receive one pre-operative dose of IV metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g) and two post-operative doses of IV metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g) 8 and 16 hours after the pre-operative dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metronidazole and cephalzolin | Drug | IV doses of metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g). One dose for study arm, two for comparative arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of post-operative infection in the six weeks following appendectomy | Defined by wound infection, fever (>38.5) or evidence of sepsis. | 6 weeks |
| Requirement of further antibiotic therapy in the six weeks following appendectomy | Administration of antibiotics either by hospital or general practitioner in the 6 week post-operative period. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to discharge taken from the time of operation to the time the child first satisfied the discharge criteria | Discharge criteria: Pain adequately controlled with oral analgesia Tolerating full diet Afebrile | 1 week |
| Re-admission in the six weeks following appendectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Mennie, MBBS | Monash University | Principal Investigator |
| Wei Cheng, MBBS | Monash Medical Centre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| C537984 | Charcot-Marie-Tooth disease, Type 1C |
| 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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Re-admission to the treating hospital or any other hospital in the 6 weeks post-operative period. |
| 6 weeks |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |