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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03312452
• Other study ID #: DBJG17-165
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: October 19, 2018

Study information

• Verified date: October 2018
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: October 19, 2018
• Est. primary completion date: October 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• Hospira plum pump
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.
• Gravity drip device
Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery.

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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