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

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Device: Gravity drip device; Device: Hospira plum pump

• Registration Number: NCT03312452
• Lead Sponsor: University of Saskatchewan

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).

Study Timeline

• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-17
• Study Start: 2018-09-01
• Status Verified: 2018-10
• Primary Completion: 2018-10-19
• Study Completion: 2018-10-19
• Last Update Submitted: 2018-10-30
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gravity drip group	Gravity drip device	Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery.
Infusion pump group	Hospira plum pump	Study subjects assigned to this group will receive intravenous fluid via an infusion pump (Hospira plum pump) during their surgery.

Primary Outcome Measures

Name	Time	Method
Average absolute difference between volume prescribed and infused	From initiation of intravenous until arrival in the recovery room, up to three hours	Difference in volume originally prescribed and ultimately administered

Secondary Outcome Measures

Name	Time	Method
Volume of intravenous fluid administered	From initiation of intravenous until arrival in the recovery room, up to three hours	Volume of fluid received over surgical course (mL/kg/hr)
Average percent difference between volume prescribed and infused	From initiation of intravenous until arrival in the recovery room, up to three hours	Percent difference in volume originally prescribed and ultimately administered

Trial Locations

Locations (1)

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada