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NCT02011230 · ClinicalTrials.gov registry record · NA

Measuring Pain and Hydration After Tonsillectomy

A NA study, sponsored by TriHealth.

Terminated
Registry status
NA
Development phase
57
Enrollment target

NCT02011230: Clinical Trial NA study, sponsored by TriHealth.

NCT02011230 is a NA study that was terminated before completion, run by TriHealth. The registered enrollment target is 57 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02011230, a NA study, was terminated before completion, sponsored by TriHealth.

TERMINATED
Registry status
NA
Development phase
57 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • OTHER Hoist Group

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2013-08
Est. Completion 2014-07
Phase NA
TriHealth

81 total trials

Why NCT02011230 stopped before completion

NCT02011230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which Hoist Group is the first listed.

NCT02011230 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02011230 about?

NCT02011230 is a clinical study titled "Measuring Pain and Hydration After Tonsillectomy". 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 ...

What is the current status of trial NCT02011230?

This trial is currently terminated. It is a NA study. The enrollment target is 57 participants. The study started on 2013-08. Estimated completion is 2014-07.

What interventions are being tested in trial NCT02011230?

The interventions under investigation include: Hoist Group (OTHER).

Who is sponsoring clinical trial NCT02011230?

This trial is sponsored by TriHealth, which has 81 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02011230's enrollment target sits among peer trials

57 1261st of 2000 higher than 739 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02011230, the US trial registry maintained by the National Library of Medicine. NCT02011230 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.