Back to resultsThe Incidence of IV Fluid Over-administration in Pediatric Dental Surgeries When Infusion Pumps Are Employed
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hospira plum pump
Gravity drip device
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring Pediatric, Perioperative, Intravenous fluid
Eligibility Criteria
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.
Sites / Locations
- University of Saskatchewan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Infusion pump group
Gravity drip group
Arm Description
Study subjects assigned to this group will receive intravenous fluid via an infusion pump (Hospira plum pump) during their surgery.
Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery.
Outcomes
Primary Outcome Measures
Average absolute difference between volume prescribed and infused
Difference in volume originally prescribed and ultimately administered
Secondary Outcome Measures
Volume of intravenous fluid administered
Volume of fluid received over surgical course (mL/kg/hr)
Average percent difference between volume prescribed and infused
Percent difference in volume originally prescribed and ultimately administered
Full Information
NCT ID
NCT03312452
First Posted
October 12, 2017
Last Updated
October 30, 2018
Sponsor
University of Saskatchewan
1. Study Identification
Unique Protocol Identification Number
NCT03312452
Brief Title
The Incidence of IV Fluid Over-administration in Pediatric Dental Surgeries When Infusion Pumps Are Employed
Official Title
The Role of Infusion Pumps in Preventing the Over-Administration of Intravenous Fluid in Pediatric Dental Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
October 19, 2018 (Actual)
Study Completion Date
October 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Pediatric, Perioperative, Intravenous fluid
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Infusion pump group
Arm Type
Experimental
Arm Description
Study subjects assigned to this group will receive intravenous fluid via an infusion pump (Hospira plum pump) during their surgery.
Arm Title
Gravity drip group
Arm Type
Active Comparator
Arm Description
Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery.
Intervention Type
Device
Intervention Name(s)
Hospira plum pump
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Gravity drip device
Intervention Description
Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery.
Primary Outcome Measure Information:
Title
Average absolute difference between volume prescribed and infused
Description
Difference in volume originally prescribed and ultimately administered
Time Frame
From initiation of intravenous until arrival in the recovery room, up to three hours
Secondary Outcome Measure Information:
Title
Volume of intravenous fluid administered
Description
Volume of fluid received over surgical course (mL/kg/hr)
Time Frame
From initiation of intravenous until arrival in the recovery room, up to three hours
Title
Average percent difference between volume prescribed and infused
Description
Percent difference in volume originally prescribed and ultimately administered
Time Frame
From initiation of intravenous until arrival in the recovery room, up to three hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duncan EJ Bowes, M.D.
Organizational Affiliation
Resident principal investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7M5M9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32761316
Citation
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.
Results Reference
derived
Learn more about this trial
The Incidence of IV Fluid Over-administration in Pediatric Dental Surgeries When Infusion Pumps Are Employed
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