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Dehydration | Measuring Pain and Hydration After Tonsillectomy

Dehydration research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Dehydration

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Hoist GroupHoist 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ControlPatients 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

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

Study Status

Terminated

Start Date: August 2013

Completed Date: July 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Incidence of dehydration

Secondary Outcome: Patient reported pain level

Study sponsors, principal investigator, and references

Principal Investigator: Eric Schwetschenau, MD

Lead Sponsor: TriHealth Inc.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02011230

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