Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03312452
Enrollment
103
Registered
2017-10-17
Start date
2018-09-01
Completion date
2018-10-19
Last updated
2018-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

Pediatric, Perioperative, Intravenous fluid

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).

Interventions

DEVICEHospira 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.

DEVICEGravity drip device

Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery.

Sponsors

University of Saskatchewan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes 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.

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Average absolute difference between volume prescribed and infusedFrom initiation of intravenous until arrival in the recovery room, up to three hoursDifference in volume originally prescribed and ultimately administered

Secondary

MeasureTime frameDescription
Volume of intravenous fluid administeredFrom initiation of intravenous until arrival in the recovery room, up to three hoursVolume of fluid received over surgical course (mL/kg/hr)
Average percent difference between volume prescribed and infusedFrom initiation of intravenous until arrival in the recovery room, up to three hoursPercent difference in volume originally prescribed and ultimately administered

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026