Effect of Pre-operative Oral Hydration on Post-operative Pain and Nausea in Adults Undergoing Tonsillectomy
Primary Purpose
Tonsil Disease, Surgical Wound, Pain, Postoperative
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oral water and clear liquids
Sponsored by
About this trial
This is an interventional prevention trial for Tonsil Disease focused on measuring Oral hydration, Tonsillectomy, Adult Surgery, Pain Control
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Beaumont HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Low fluid intake
Medium fluid intake
High fluid intake
Arm Description
0.5 L - 1.5 L fluid intake in the 24 hours prior to NPO status for surgery
1.5 L - 3 L fluid intake in the 24 hours prior to NPO status for surgery
3 L - 4.5 L fluid intake in the 24 hours prior to NPO status for surgery
Outcomes
Primary Outcome Measures
Pain 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
Participant reported nausea on a Likert scale from 0-10, where 0=no nausea and 10 = worst nausea possible.
Secondary Outcome Measures
Pain postoperative
Participant reported pain on a Likert scale from 0-10, where 0=no pain and 10= worst pain possible.
Nausea postoperative
Participant reported nausea on a Likert scale from 0-10, where 0=no nausea and 10 =
Narcotic pain medication use immediately following surgery
Opioid pain medication administered in Post-Anesthesia Care Unit (PACU) in morphine equivalents
Nausea medication use immediately following surgery
Oral anti-nausea medication administered in Post-Anesthesia Care Unit (PACU)
Narcotic pain medication use after discharge
Opioid pain medication used after discharge in morphine equivalents
Nausea medication use after discharge
Oral anti-nausea medication (4 mg zofran) used after discharge
Full Information
NCT ID
NCT05507918
First Posted
August 17, 2022
Last Updated
July 11, 2023
Sponsor
William Beaumont Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT05507918
Brief Title
Effect of Pre-operative Oral Hydration on Post-operative Pain and Nausea in Adults Undergoing Tonsillectomy
Official Title
Effect of Pre-operative Oral Hydration on Post-operative Pain and Nausea in Adults Undergoing Tonsillectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsil Disease, Surgical Wound, Pain, Postoperative
Keywords
Oral hydration, Tonsillectomy, Adult Surgery, Pain Control
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 group parallel comparison, non-blinded, interventional
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low fluid intake
Arm Type
Experimental
Arm Description
0.5 L - 1.5 L fluid intake in the 24 hours prior to NPO status for surgery
Arm Title
Medium fluid intake
Arm Type
Experimental
Arm Description
1.5 L - 3 L fluid intake in the 24 hours prior to NPO status for surgery
Arm Title
High fluid intake
Arm Type
Experimental
Arm Description
3 L - 4.5 L fluid intake in the 24 hours prior to NPO status for surgery
Intervention Type
Other
Intervention Name(s)
Oral water and clear liquids
Other Intervention Name(s)
Oral Hydration
Intervention Description
Measured oral intake of fluids prior to tonsillectomy
Primary Outcome Measure Information:
Title
Pain 8 hours postoperative
Description
Participant reported pain on a Likert scale from 0-10, where 0=no pain and 10= worst pain possible.
Time Frame
8 hours postoperative
Title
Nausea 4 hours postoperative
Description
Participant reported nausea on a Likert scale from 0-10, where 0=no nausea and 10 = worst nausea possible.
Time Frame
4 hours postoperative
Secondary Outcome Measure Information:
Title
Pain postoperative
Description
Participant reported pain on a Likert scale from 0-10, where 0=no pain and 10= worst pain possible.
Time Frame
up to 7 days postoperative
Title
Nausea postoperative
Description
Participant reported nausea on a Likert scale from 0-10, where 0=no nausea and 10 =
Time Frame
up to 7 days postoperative
Title
Narcotic pain medication use immediately following surgery
Description
Opioid pain medication administered in Post-Anesthesia Care Unit (PACU) in morphine equivalents
Time Frame
4 hours
Title
Nausea medication use immediately following surgery
Description
Oral anti-nausea medication administered in Post-Anesthesia Care Unit (PACU)
Time Frame
4 hours
Title
Narcotic pain medication use after discharge
Description
Opioid pain medication used after discharge in morphine equivalents
Time Frame
up to 14 days postoperative
Title
Nausea medication use after discharge
Description
Oral anti-nausea medication (4 mg zofran) used after discharge
Time Frame
up to 14 days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jake Sims, DO
Phone
248-888-2609
Email
jake.sims@beaumont.org
First Name & Middle Initial & Last Name or Official Title & Degree
Bobbie Lewis, RN
Phone
248-551-5958
Email
bobbie.lewis@beaumont.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Farrugia, DO
Organizational Affiliation
Beaumont Health - Farmington Hills
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Hospital
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bobbie Lewis, RN
Phone
248-551-5958
Email
bobbie.lewis@beaumont.org
First Name & Middle Initial & Last Name & Degree
Jake Sims, DO
Phone
248-888-2609
Email
jake.sims@beaumont.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Pre-operative Oral Hydration on Post-operative Pain and Nausea in Adults Undergoing Tonsillectomy
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