Measuring Pain and Hydration After Tonsillectomy

NCT ID: NCT02011230

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Hoist

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

Group Type: EXPERIMENTAL

Hoist Group

Intervention Type: 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

Interventions

Hoist Group

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

Intervention Type: OTHER

Other Intervention Names

Hoist

Eligibility Criteria

Inclusion Criteria

• Patients undergoing tonsillectomy
• Patients undergoing tonsillectomy with adenoidectomy

Exclusion Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 98 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Angela N Fellner PhD CCRP

Clinical Research Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Schwetschenau, MD

Role: PRINCIPAL_INVESTIGATOR

TriHealth Inc.

Locations

Queen City ENT

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

13022

Identifier Type: -

Identifier Source: org_study_id