DehydrationNCT02011230
Measuring Pain and Hydration After Tonsillectomy
A study testing Hoist Group in people with Dehydration, run by TriHealth Inc. at 1 site in United States.
Trial 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%. Read more about this study
- Who is it for?
- Ages 4 to 98 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Hoist Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 98 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing tonsillectomy
- Patients undergoing tonsillectomy with adenoidectomy
Who cannot join
- Patients on anticoagulants
- Patients younger than 3 years old
- Patients with chronic pain syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Control as a Function of Hydration Status in the Post Tonsillectomy Patient.
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.
Read more
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.
- Conditions
- Dehydration
- Being tested
- Hoist Group
- Keywords
- 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
- Medical subject headings
- Dehydration, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hoist GroupOther
Also called Hoist
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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 |
| Hoist | Experimental | Patients in the Hoist group will be given a 10 day supply of Hoist that they will self administer Receives: Other: Hoist Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dehydration
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.
Measured: 0-10 days
Secondary outcomes (1)
Patient reported pain level
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
Measured: 0-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: IRB closed study: irregularities in documentation of informed consent, HIPAA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela N Fellner PhD CCRP, TriHealth Inc.
- Investigators
- Eric Schwetschenau, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011230
- Sponsor's protocol ID
- 13022
- Status last verified
- Aug 2018
- First submitted
- 3 Dec 2013
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Study terminated
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Control as a Function of Hydration Status in the Post Tonsillectomy Patient.
- ClinicalTrials.gov ID
- NCT02011230
- Acronym / sponsor ID
- 13022
- Conditions
- Dehydration
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB closed study: irregularities in documentation of informed consent, HIPAA
- Enrolment
- 57 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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 |
| Hoist | Experimental | Other: Hoist GroupPatients in the Hoist group will be given a 10 day supply of Hoist that they will self administer |
Who may qualify
- Ages
- 4 to 98 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing tonsillectomy
- Patients undergoing tonsillectomy with adenoidectomy
Key exclusion criteria (3 listed)
- Patients on anticoagulants
- Patients younger than 3 years old
- Patients with chronic pain syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hoist GroupAlso: HoistHoist 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 | Hoist |
Primary outcome
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.
1 secondary outcome
Patient reported pain level
Time frame: 0-10 days
Results and safety
The study was stopped early (reason given: IRB closed study: irregularities in documentation of informed consent, HIPAA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Individual participant dataSharing planned: No. Study terminated
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Schwetschenau, MD principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hoist Group in people with Dehydration, run by TriHealth Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: IRB closed study: irregularities in documentation of informed consent, HIPAA). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dehydration (time frame: 0-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.