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A prospective, analyst-blinded, randomized control trial to assess the incidence of intravenous (IV) fluid over-administration in the setting of pediatric dental surgeries. Anesthetists will be randomized to either administer their IV fluid through an infusion pump or a gravity drip device.
In the perioperative setting, IV fluids are administered to mitigate the effects of preoperative fasting and sources of fluid loss that are unique to surgical intervention. Significant harms have been associated with the over-administration of IV fluid in pediatric patients. Infusion pumps have been shown to reduce medication administration errors in inpatients receiving continuous IV infusions. In contrast, laboratory experiments have demonstrated that gravity driven fluid delivery systems are influenced by numerous extrinsic factors. To date, no work has investigated the perioperative incidence of IV fluid over-administration in pediatric patients randomized either to infusion pumps (intervention) or gravity-fed IV systems (control).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infusion pump group | Experimental | Study subjects assigned to this group will receive intravenous fluid via an infusion pump (Hospira plum pump) during their surgery. |
|
| Gravity drip group | Active Comparator | Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hospira plum pump | Device | The Hospira plum pump enables the clinician to program a specific volume of intravenous fluid and define a period of time over which to administer this fluid. |
| Measure | Description | Time Frame |
|---|---|---|
| Average absolute difference between volume prescribed and infused | Difference in volume originally prescribed and ultimately administered | From initiation of intravenous until arrival in the recovery room, up to three hours |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of intravenous fluid administered | Volume of fluid received over surgical course (mL/kg/hr) | From initiation of intravenous until arrival in the recovery room, up to three hours |
| Average percent difference between volume prescribed and infused |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duncan EJ Bowes, M.D. | Resident principal investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Saskatchewan | Saskatoon | Saskatchewan | S7M5M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32761316 | Derived | Bowes DE, Gamble JJ, Bajwa JS. Using automated pump-delivery devices to reduce the incidence of excessive fluid administration during pediatric dental surgery: a randomized-controlled trial. Can J Anaesth. 2020 Nov;67(11):1535-1540. doi: 10.1007/s12630-020-01776-4. Epub 2020 Aug 5. |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Participants will blinded to group allocation by concealment of the IV fluid delivery device in the operating room. Analysts will be presented with data that has been coded to conceal each participants' allocation to either the intervention or control group.
| Gravity drip device | Device | Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery. |
|
Percent difference in volume originally prescribed and ultimately administered
| From initiation of intravenous until arrival in the recovery room, up to three hours |