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

NCT03312452 | Completed

• 1 other identifier: DBJG17-165
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

Pediatric; Perioperative; Intravenous fluid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Volume of intravenous fluid administered

  From initiation of intravenous until arrival in the recovery room, up to three hours

• Average percent difference between volume prescribed and infused

  From initiation of intravenous until arrival in the recovery room, up to three hours

Study Arms (2)

Infusion pump group

EXPERIMENTAL

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

Device: Hospira plum pump

Gravity drip group

ACTIVE COMPARATOR

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

Device: Gravity drip device

Interventions

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.

Infusion pump group

Gravity drip device DEVICE

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

Gravity drip group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA 1 and 2 children presenting for dental surgery

You may not qualify if:

• Children with pre-existing cardiac, renal, pulmonary or endocrine disease. In addition any child with an ASA score of 3 or greater.

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7M5M9, Canada

Location

Related Publications (1)

• 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.

  PMID: 32761316 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Duncan EJ Bowes, M.D.

  Resident principal investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 17, 2017
• Study Start: September 1, 2018
• Primary Completion: October 19, 2018
• Study Completion: October 19, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)