Effect of Pre-operative Oral Hydration on Post-operative Pain and Nausea in Adults Undergoing Tonsillectomy

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.

Study Overview

• Status: Withdrawn
• Conditions: Pain, Postoperative; Surgical Wound; Tonsil Disease
• Intervention / Treatment: Other: Oral water and clear liquids

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jake Sims, DO; Phone Number: 248-888-2609; Email: jake.sims@beaumont.org
• Study Contact Backup: Name: Bobbie Lewis, RN; Phone Number: 248-551-5958; Email: bobbie.lewis@beaumont.org

Study Locations

• United States
  • Michigan
    • Farmington Hills, Michigan, United States, 48336
      • Recruiting
      • Beaumont Hospital
      • Contact: Jake Sims, DO; Phone Number: 248-888-2609; Email: jake.sims@beaumont.org
      • Contact: Bobbie Lewis, RN; Phone Number: 248-551-5958; Email: bobbie.lewis@beaumont.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low fluid intake; 0.5 L - 1.5 L fluid intake in the 24 hours prior to NPO status for surgery	Other: Oral water and clear liquids; Measured oral intake of fluids prior to tonsillectomy; Other Names: Oral Hydration
Experimental: Medium fluid intake; 1.5 L - 3 L fluid intake in the 24 hours prior to NPO status for surgery	Other: Oral water and clear liquids; Measured oral intake of fluids prior to tonsillectomy; Other Names: Oral Hydration
Experimental: High fluid intake; 3 L - 4.5 L fluid intake in the 24 hours prior to NPO status for surgery	Other: Oral water and clear liquids; Measured oral intake of fluids prior to tonsillectomy; Other Names: Oral Hydration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain 8 hours postoperative	Participant reported pain on a Likert scale from 0-10, where 0=no pain and 10= worst pain possible.	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.	4 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain postoperative	Participant reported pain on a Likert scale from 0-10, where 0=no pain and 10= worst pain possible.	up to 7 days postoperative
Nausea postoperative	Participant reported nausea on a Likert scale from 0-10, where 0=no nausea and 10 =	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	4 hours
Nausea medication use immediately following surgery	Oral anti-nausea medication administered in Post-Anesthesia Care Unit (PACU)	4 hours
Narcotic pain medication use after discharge	Opioid pain medication used after discharge in morphine equivalents	up to 14 days postoperative
Nausea medication use after discharge	Oral anti-nausea medication (4 mg zofran) used after discharge	up to 14 days postoperative

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Investigators: Principal Investigator: Matthew Farrugia, DO, Beaumont Health - Farmington Hills

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Tonsillectomy; Pain Control; Oral hydration; Adult Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Pain, Postoperative; Surgical Wound
• Other Study ID Numbers: 2022-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No