Clinical trial NCT02011230: Measuring Pain and Hydration After Tonsillectomy
Official title: Pain Control as a Function of Hydration Status in the Post Tonsillectomy Patient.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 57
Sex: ALL
Minimum age (years): 4
Maximum age (years): 98
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of dehydration
timeFrame: 0-10 days
Secondary outcomes:
measure: Patient reported pain level
timeFrame: 0-10 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Queen City ENT
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Eric Schwetschenau, MD
role: PRINCIPAL_INVESTIGATOR
References: