- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03312452
The Incidence of IV Fluid Over-administration in Pediatric Dental Surgeries When Infusion Pumps Are Employed
October 30, 2018 updated by: Jonathan Gamble, University of Saskatchewan
The Role of Infusion Pumps in Preventing the Over-Administration of Intravenous Fluid in Pediatric Dental Surgeries
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7M5M9
- University of Saskatchewan
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Infusion pump group
Study subjects assigned to this group will receive intravenous fluid via an infusion pump (Hospira plum pump) during their surgery.
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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.
|
Active Comparator: Gravity drip group
Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery.
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Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average absolute difference between volume prescribed and infused
Time Frame: From initiation of intravenous until arrival in the recovery room, up to three hours
|
Difference in volume originally prescribed and ultimately administered
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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
Time Frame: From initiation of intravenous until arrival in the recovery room, up to three hours
|
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
Time Frame: From initiation of intravenous until arrival in the recovery room, up to three hours
|
Percent difference in volume originally prescribed and ultimately administered
|
From initiation of intravenous until arrival in the recovery room, up to three hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Duncan EJ Bowes, M.D., Resident principal investigator
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Actual)
October 19, 2018
Study Completion (Actual)
October 19, 2018
Study Registration Dates
First Submitted
October 12, 2017
First Submitted That Met QC Criteria
October 16, 2017
First Posted (Actual)
October 17, 2017
Study Record Updates
Last Update Posted (Actual)
October 31, 2018
Last Update Submitted That Met QC Criteria
October 30, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DBJG17-165
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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