Measuring Pain and Hydration After Tonsillectomy
|ClinicalTrials.gov 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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02011230
|United States, Ohio|
|Queen City ENT|
|Cincinnati, Ohio, United States, 45249|
|Principal Investigator:||Eric Schwetschenau, MD||TriHealth Inc.|