Measuring Pain and Hydration After Tonsillectomy

TriHealth

Status: Terminated

Conditions: Dehydration

Treatments: Other: Hoist Group

Study type: Interventional

Funder types: Other

Identifiers

NCT02011230

13022

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 4 to 98 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Control

No Intervention group

Description:

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 group

Description:

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

Treatment:

Other: Hoist Group