Measuring Pain and Hydration After Tonsillectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02011230
Recruitment Status : Terminated (IRB closed study: irregularities in documentation of informed consent, HIPAA)
First Posted : December 13, 2013
Last Update Posted : August 11, 2016
Information provided by (Responsible Party):
Angela Fellner, TriHealth Inc.

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.

Condition or disease Intervention/treatment Phase
Dehydration Other: Hoist Group Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pain Control as a Function of Hydration Status in the Post Tonsillectomy Patient.
Study Start Date : August 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 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
Experimental: Hoist
Patients in the Hoist group will be given a 10 day supply of Hoist that they will self administer
Other: 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
Other Name: Hoist

Primary Outcome Measures :
  1. Incidence of dehydration [ Time Frame: 0-10 days ]
    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.

Secondary Outcome Measures :
  1. Patient reported pain level [ Time Frame: 0-10 days ]
    Patients will take a survey for up to 10 days after tonsillectomy to rate their level of pain each day. This will be used to see a correlation between reported pain level and amount of fluid intake each day

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   4 Years to 98 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02011230

United States, Ohio
Queen City ENT
Cincinnati, Ohio, United States, 45249
Sponsors and Collaborators
TriHealth Inc.
Principal Investigator: Eric Schwetschenau, MD TriHealth Inc.

Responsible Party: Angela Fellner, Clinical Research Specialist, TriHealth Inc. Identifier: NCT02011230     History of Changes
Other Study ID Numbers: 13022
First Posted: December 13, 2013    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study terminated

Keywords provided by Angela Fellner, TriHealth Inc.:
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

Additional relevant MeSH terms:
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes