Measuring Pain and Hydration After Tonsillectomy

Not Applicable

Terminated

• Conditions: Dehydration
• Interventions: Other: Hoist Group

• Registration Number: NCT02011230
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-13
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hoist	Hoist Group	Patients in the Hoist group will be given a 10 day supply of Hoist that they will self administer

Primary Outcome Measures

Name	Time	Method
Incidence of dehydration	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

Name	Time	Method
Patient reported pain level	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

Trial Locations

Locations (1)

Queen City ENT; 🇺🇸 Cincinnati, Ohio, United States