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Completed

NCT Number: NCT03312452

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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7M5M9, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hospira plum pump

Device

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

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2017
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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