Measuring Pain and Hydration After Tonsillectomy

NCT02011230 | Terminated DMC

• 1 other identifier: 13022
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Pain after tonsillectomy remains a key barrier during the post operative period. The published return rate to the emergency department for hydration and pain control is approximately 4%. If we can demonstrate decreased pain or decreased visits to the emergency department post tonsillectomy, patient experiences will be improved and health care dollars spent will be decreased. We will attempt to improve hydration status by encouraging consumption of a novel isotonic hydration solution that is currently commercially available. Our study hypothesis is that patients provided an isotonic hydration solution and instructions on avoiding dehydration post operatively will have improved pain control and decreased emergency department visits. Improvement in hydration status has the potential of decreasing emergency room visits and subsequent decrease in spending of healthcare dollars. Additional benefits of post-operative hydration may include decrease in pain and decrease in post-operative bleeding rates. A new isotonic hydration solution with an improved flavor profile (Hoist®) has recently become commercially available. Itis very similar to that of Pedialyte, a commonly used rehydration solution. Pedialyte was designed for rehydration of infants and small children. It has a taste that is not acceptable to many adults and older children. This study will implement the use of Hoist as suitable rehydration solution. This study is designed to define the relationship between improvement of patient's hydration through provision of a rehydration solution during the post operative period and decrease in complications requiring return to the emergency room, including dehydration and bleeding, as well as improvement in overall pain control.

Conditions

Dehydration

Keywords

Dehydration; Hoist; pain control; The intervention is to provide a commercially available isotonic hydration solution (Hoist®) to the patients.; Patients will drink this solution post procedure as needed.; Patients in the control group will use their discretion to drink any solution they feel suitable

Outcome Measures

Primary Outcomes (1)

• Incidence of dehydration

  Patients in the Hoist group will be given a 10 day supply of Hoist (22 bottles). Patients will self-administer the Hoist solution (Parents will administer the Hoist in the case of minor study participants) Pain will be measured during the recovery phase for ten days. Patients will be asked to rate their pain level each day post op (days 0-10) using a numeric pain intensity scale in addition, children ages 4-12 will also receive a Wong-Baker FACES pain scale.

  0-10 days

Secondary Outcomes (1)

• Patient reported pain level

  0-10 days

Study Arms (2)

Control

NO INTERVENTION

Patients in the control group will not be given any special fluids to take after surgery Patients will use their discretion to drink as needed following surgery

Hoist

EXPERIMENTAL

Patients in the Hoist group will be given a 10 day supply of Hoist that they will self administer

Other: Hoist Group

Interventions

Hoist Group OTHER

Hoist is a commercially available drink that is sold locally. This solution is isotonic meaning that it contains similar concentrations of salt and sugar that are found in the human body

Also known as: Hoist

Hoist

Eligibility Criteria

• Age: 4 Years - 98 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing tonsillectomy
• Patients undergoing tonsillectomy with adenoidectomy

You may not qualify if:

• Patients on anticoagulants
• Patients younger than 3 years old
• Patients with chronic pain syndrome

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Queen City ENT

Cincinnati, Ohio, 45249, United States

Location

MeSH Terms

Conditions

Dehydration; Agnosia

Interventions

Lifting

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Study Officials

• Eric Schwetschenau, MD

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Specialist

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 13, 2013
• Study Start: August 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)