Tonsil DiseaseNCT05507918
Effect of Pre-operative Oral Hydration on Post-operative Pain and Nausea in Adults Undergoing Tonsillectomy
A study testing Oral water and clear liquids in people with Tonsil Disease and Surgical Wound, run by Corewell Health East.
Trial summary
Tonsillectomy is commonly described as one of the most painful procedures that an adult can undergo. This study's aim is to evaluate if pre-operative oral hydration has an impact in reducing post-operative pain, nausea and vomiting, and opioid medication use after adult tonsillectomies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tonsil Disease, Surgical Wound, Pain, Postoperative
- What is being tested?
- Oral water and clear liquids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Apr 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult undergoing primary tonsillectomy or any procedure which includes tonsillectomy as component at Beaumont Farmington Hills Hospital or Novi Surgery Center.
- Patients greater than or equal to 18 years of age
Who cannot join
- Patients < 18 years of age
- Decisionally impaired
- Adults with history of significant gastro-esophageal pathology (ie. gastric/duodenal ulcers, Barrett's esophagus, eosinophilic esophagitis)
- Patient undergoing tonsillectomy procedure due to previous or active peri-tonsillar abscess or for resection of cancer
- Allergy or contraindication to the use of acetaminophen or narcotic medications
- Pregnant
Show all 9Show fewer
- Patients that have chronic disease states including chronic kidney disease, congestive heart failure, diabetes mellitus, diabetes insipidus, or chronic pain syndrome
- Patients that are on chronic pain medications, diuretics or steroids
- Patients that have history of significant nausea/vomiting associated with anesthesia
About this study
Tonsillectomy is commonly described as one of the most painful procedures that an adult can undergo. This study's aim is to evaluate if pre-operative oral hydration has an impact in reducing post-operative pain, nausea and vomiting, and opioid medication use after adult tonsillectomies. Participants will be randomized to a low, medium and high fluid intake groups and will record fluid intake on the day before surgery. After surgery, participants will record their pain and nausea at timepoints up to 7 days post-operative. Medication use will be recorded up to the first post-operative follow-up visit with their physician.
Read the detailed description
Common indications for adult tonsillectomy include tonsillar hypertrophy, obstructive sleep apnea, and chronic tonsillitis. Although there are many studies looking into how best to prevent and treat post-operative pain and nausea, there are very few that give recommendations to the patients pre-operatively. This study's aim is to evaluate if pre-operative oral hydration has an impact in reducing post-operative pain, nausea and vomiting after adult tonsillectomies. If pre-operative hydration can reduce the pain associated with the procedure, then this could also be an adjunct to help reduce the amount of narcotic pain medication that is required.
The goal of this study is to evaluate if the amount of pre-operative oral hydration can reduce the amount of pain and nausea/vomiting in patients undergoing adult tonsillectomies. This study will be measuring post-operative pain and nausea scores at several points after the adult tonsillectomy procedure for participants that have consumed different amounts of clear fluid in the 24 hours leading up to their nothing by mouth (NPO) status. Participants will be randomized to one of three categories of preoperative fluid: 0.5 - 1.5 Liters (L), 1.5 - 3 L, and 3 - 4.5 L, which will correlate to the low, medium and high fluid intake groups, respectively. Participants will be given a 1000 mL measuring water bottle that they can use to accurately record their fluid consumption in the 24 hours prior to their pre-operative NPO status. The fluid consumption that they record will include all liquids (i.e., water, flavored water, juice, coffee, tea, soda, milk, alcohol). They will be asked to keep a record of the volume of caffeinated beverage versus un-caffeinated beverages.
After surgery the participants will be given a form to record their pain and nausea scores. Participants will record their pain and nausea by using two separate 10-point scales at 7 different points after the procedure. These scores will be measured immediately after surgery, and at 4 hours, 8 hours, 24 hours, 72 hours, 5 days and 7 days postoperative. This form, along with a count of opioid medication used, will be retuned to the physician at the first post-operative follow-up visit.
- Conditions
- Tonsil Disease, Surgical Wound, Pain, Postoperative
- Being tested
- Oral water and clear liquids
- Keywords
- Oral hydration, Tonsillectomy, Adult Surgery, Pain Control
- Medical subject headings
- Surgical Wound, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral water and clear liquidsOther
Also called Oral Hydration
Measured oral intake of fluids prior to tonsillectomy
| Study group | Role | What they receive |
|---|---|---|
| Low fluid intake | Experimental | 0.5 L - 1.5 L fluid intake in the 24 hours prior to NPO status for surgery Receives: Other: Oral water and clear liquids |
| Medium fluid intake | Experimental | 1.5 L - 3 L fluid intake in the 24 hours prior to NPO status for surgery Receives: Other: Oral water and clear liquids |
| High fluid intake | Experimental | 3 L - 4.5 L fluid intake in the 24 hours prior to NPO status for surgery Receives: Other: Oral water and clear liquids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain 8 hours postoperative
Participant reported pain on a Likert scale from 0-10, where 0=no pain and 10= worst pain possible.
Measured: 8 hours postoperative
Nausea 4 hours postoperative
Participant reported nausea on a Likert scale from 0-10, where 0=no nausea and 10 = worst nausea possible.
Measured: 4 hours postoperative
Secondary outcomes (6)
Pain postoperative
Participant reported pain on a Likert scale from 0-10, where 0=no pain and 10= worst pain possible.
Measured: up to 7 days postoperative
Nausea postoperative
Participant reported nausea on a Likert scale from 0-10, where 0=no nausea and 10 =
Measured: up to 7 days postoperative
Narcotic pain medication use immediately following surgery
Opioid pain medication administered in Post-Anesthesia Care Unit (PACU) in morphine equivalents
Measured: 4 hours
Nausea medication use immediately following surgery
Oral anti-nausea medication administered in Post-Anesthesia Care Unit (PACU)
Measured: 4 hours
Narcotic pain medication use after discharge
Opioid pain medication used after discharge in morphine equivalents
Measured: up to 14 days postoperative
Nausea medication use after discharge
Oral anti-nausea medication (4 mg zofran) used after discharge
Measured: up to 14 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study startApr 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Why it stopped: limitations in staff and resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tonsil DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 group parallel comparison, non-blinded, interventional
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Farrugia, Corewell Health East
- Investigators
- Matthew Farrugia, DO, Principal investigator, Beaumont Health - Farmington Hills
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507918
- Sponsor's protocol ID
- 2022-017
- Status last verified
- Apr 2024
- First submitted
- 17 Aug 2022
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-operative Oral Hydration on Post-operative Pain and Nausea in Adults Undergoing Tonsillectomy
- ClinicalTrials.gov ID
- NCT05507918
- Acronym / sponsor ID
- 2022-017
- Conditions
- Tonsil Disease, Surgical Wound, Pain, Postoperative
- Keywords
- Oral hydration, Tonsillectomy, Adult Surgery, Pain Control
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: limitations in staff and resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 19 Aug 2022 (actual)
- 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.
Tonsillectomy is commonly described as one of the most painful procedures that an adult can undergo. This study's aim is to evaluate if pre-operative oral hydration has an impact in reducing post-operative pain, nausea and vomiting, and opioid medication use after adult tonsillectomies. Participants will be randomized to a low, medium and high fluid intake groups and will record fluid intake on the day before surgery. After surgery, participants will record their pain and nausea at timepoints up to 7 days post-operative. Medication use will be recorded up to the first post-operative follow-up visit with their physician.
Detailed description
Common indications for adult tonsillectomy include tonsillar hypertrophy, obstructive sleep apnea, and chronic tonsillitis. Although there are many studies looking into how best to prevent and treat post-operative pain and nausea, there are very few that give recommendations to the patients pre-operatively. This study's aim is to evaluate if pre-operative oral hydration has an impact in reducing post-operative pain, nausea and vomiting after adult tonsillectomies. If pre-operative hydration can reduce the pain associated with the procedure, then this could also be an adjunct to help reduce the amount of narcotic pain medication that is required.
The goal of this study is to evaluate if the amount of pre-operative oral hydration can reduce the amount of pain and nausea/vomiting in patients undergoing adult tonsillectomies. This study will be measuring post-operative pain and nausea scores at several points after the adult tonsillectomy procedure for participants that have consumed different amounts of clear fluid in the 24 hours leading up to their nothing by mouth (NPO) status. Participants will be randomized to one of three categories of preoperative fluid: 0.5 - 1.5 Liters (L), 1.5 - 3 L, and 3 - 4.5 L, which will correlate to the low, medium and high fluid intake groups, respectively. Participants will be given a 1000 mL measuring water bottle that they can use to accurately record their fluid consumption in the 24 hours prior to their pre-operative NPO status. The fluid consumption that they record will include all liquids (i.e., water, flavored water, juice, coffee, tea, soda, milk, alcohol). They will be asked to keep a record of the volume of caffeinated beverage versus un-caffeinated beverages.
After surgery the participants will be given a form to record their pain and nausea scores. Participants will record their pain and nausea by using two separate 10-point scales at 7 different points after the procedure. These scores will be measured immediately after surgery, and at 4 hours, 8 hours, 24 hours, 72 hours, 5 days and 7 days postoperative. This form, along with a count of opioid medication used, will be retuned to the physician at the first post-operative follow-up visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 group parallel comparison, non-blinded, interventional
| Arm | Type | Receives |
|---|---|---|
| Low fluid intake | Experimental | Other: Oral water and clear liquids0.5 L - 1.5 L fluid intake in the 24 hours prior to NPO status for surgery |
| Medium fluid intake | Experimental | Other: Oral water and clear liquids1.5 L - 3 L fluid intake in the 24 hours prior to NPO status for surgery |
| High fluid intake | Experimental | Other: Oral water and clear liquids3 L - 4.5 L fluid intake in the 24 hours prior to NPO status for surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult undergoing primary tonsillectomy or any procedure which includes tonsillectomy as component at Beaumont Farmington Hills Hospital or Novi Surgery Center.
- Patients greater than or equal to 18 years of age
Key exclusion criteria (9 listed)
- Patients < 18 years of age
- Decisionally impaired
- Adults with history of significant gastro-esophageal pathology (ie. gastric/duodenal ulcers, Barrett's esophagus, eosinophilic esophagitis)
- Patient undergoing tonsillectomy procedure due to previous or active peri-tonsillar abscess or for resection of cancer
- Allergy or contraindication to the use of acetaminophen or narcotic medications
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 |
|---|---|---|
| Oral water and clear liquidsAlso: Oral HydrationMeasured oral intake of fluids prior to tonsillectomy | Other | High fluid intake, Low fluid intake, Medium fluid intake |
Primary outcome
Pain 8 hours postoperative
Time frame: 8 hours postoperative
Participant reported pain on a Likert scale from 0-10, where 0=no pain and 10= worst pain possible.
Nausea 4 hours postoperative
Time frame: 4 hours postoperative
Participant reported nausea on a Likert scale from 0-10, where 0=no nausea and 10 = worst nausea possible.
6 secondary outcomes
Pain postoperative
Time frame: up to 7 days postoperative
Nausea postoperative
Time frame: up to 7 days postoperative
Narcotic pain medication use immediately following surgery
Time frame: 4 hours
Nausea medication use immediately following surgery
Time frame: 4 hours
Narcotic pain medication use after discharge
Time frame: up to 14 days postoperative
Nausea medication use after discharge
Time frame: up to 14 days postoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Matthew Farrugia, DO principal investigator
Beaumont Health - Farmington Hills
Questions about this trial
What is this clinical trial studying?
A study testing Oral water and clear liquids in people with Tonsil Disease and Surgical Wound, run by Corewell Health East.
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 9 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: withdrawn, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Pain 8 hours postoperative (time frame: 8 hours postoperative). The study lists 2 primary outcomes in all. 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 4 Apr 2024.