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

NCT ID: NCT03312452

Last Updated: 2018-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2018-10-19

Brief Summary

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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

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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).

Conditions

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Dental Caries

Keywords

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Pediatric Perioperative Intravenous fluid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Infusion pump group

Study subjects assigned to this group will receive intravenous fluid via an infusion pump (Hospira plum pump) during their surgery.

Group Type EXPERIMENTAL

Hospira plum pump

Intervention Type 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 group

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

Group Type ACTIVE_COMPARATOR

Gravity drip device

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Gravity drip device

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Gamble

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duncan EJ Bowes, M.D.

Role: PRINCIPAL_INVESTIGATOR

Resident principal investigator

Locations

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University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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Bowes DE, Gamble JJ, Bajwa JS. Using automated pump-delivery devices to reduce the incidence of excessive fluid administration during pediatric dental surgery: a randomized-controlled trial. Can J Anaesth. 2020 Nov;67(11):1535-1540. doi: 10.1007/s12630-020-01776-4. Epub 2020 Aug 5.

Reference Type DERIVED
PMID: 32761316 (View on PubMed)

Other Identifiers

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DBJG17-165

Identifier Type: -

Identifier Source: org_study_id