The Incidence of IV Fluid Over-administration in Pediatric Dental Surgeries When Infusion Pumps Are Employed

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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The Role of Infusion Pumps in Preventing the Over-Administration of Intravenous Fluid in Pediatric Dental Surgeries

Conditions
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Dental Caries

Intervention / Treatment
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* Device: Hospira plum pump
* Device: Gravity drip device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1 and 2 children presenting for dental surgery Exclusion Criteria: Children with pre-existing cardiac, renal, pulmonary or endocrine disease. In addition any child with an ASA score of 3 or greater.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infusion pump group<br>Study subjects assigned to this group will receive intravenous fluid via an infusion pump (Hospira plum pump) during their surgery. | Device: Hospira plum pump<br>* 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.<br>|
| Active Comparator: Gravity drip group<br>Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery. | Device: Gravity drip device<br>* Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Percent difference in volume originally prescribed and ultimately administered | From initiation of intravenous until arrival in the recovery room, up to three hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perioperative, Pediatric, Intravenous fluid