Measuring Pain and Hydration After Tonsillectomy

This study is currently recruiting participants.
Verified December 2013 by TriHealth Inc.
Sponsor:
Information provided by (Responsible Party):
Tiffany Forde, TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT02011230
First received: December 3, 2013
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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 Intervention
Dehydration
Other: Hoist Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pain Control as a Function of Hydration Status in the Post Tonsillectomy Patient.

Resource links provided by NLM:


Further study details as provided by TriHealth Inc.:

Primary Outcome Measures:
  • Incidence of dehydration [ Time Frame: 0-10 days ] [ Designated as safety issue: No ]
    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:
  • Patient reported pain level [ Time Frame: 0-10 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 200
Study Start Date: August 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02011230

Locations
United States, Ohio
Queen City ENT Recruiting
Cincinnati, Ohio, United States, 45249
Contact: Tiffany Forde, MS    513-865-5226    tiffany_forde@trihealth.com   
Principal Investigator: Eric Schwetschenau, MD         
Sponsors and Collaborators
TriHealth Inc.
Investigators
Principal Investigator: Eric Schwetschenau, MD TriHealth Inc.
  More Information

No publications provided

Responsible Party: Tiffany Forde, Clinical Research Specialist, TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02011230     History of Changes
Other Study ID Numbers: 13022
Study First Received: December 3, 2013
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by TriHealth Inc.:
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

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

ClinicalTrials.gov processed this record on April 22, 2014