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

Sponsor

William Beaumont Hospitals (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05507918

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tonsil Disease Surgical Wound Pain, Postoperative	Other: Oral water and clear liquids	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

3 group parallel comparison, non-blinded, interventional3 group parallel comparison, non-blinded, interventional

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 30, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain 8 hours postoperative [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 [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 [up to 7 days postoperative]
Participant reported pain on a Likert scale from 0-10, where 0=no pain and 10= worst pain possible.
Nausea postoperative [up to 7 days postoperative]
Participant reported nausea on a Likert scale from 0-10, where 0=no nausea and 10 =
Narcotic pain medication use immediately following surgery [4 hours]
Opioid pain medication administered in Post-Anesthesia Care Unit (PACU) in morphine equivalents
Nausea medication use immediately following surgery [4 hours]
Oral anti-nausea medication administered in Post-Anesthesia Care Unit (PACU)
Narcotic pain medication use after discharge [up to 14 days postoperative]
Opioid pain medication used after discharge in morphine equivalents
Nausea medication use after discharge [up to 14 days postoperative]
Oral anti-nausea medication (4 mg zofran) used after discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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