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

NCT05507918 | Withdrawn

• 1 other identifier: 2022-017
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tonsil Disease; Surgical Wound; Pain, Postoperative

Keywords

Oral hydration; Tonsillectomy; Adult Surgery; Pain Control

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Pain postoperative

  up to 7 days postoperative

• Nausea postoperative

  up to 7 days postoperative

• Narcotic pain medication use immediately following surgery

  4 hours

• Nausea medication use immediately following surgery

  4 hours

• Narcotic pain medication use after discharge

  up to 14 days postoperative

Study Arms (3)

Low fluid intake

EXPERIMENTAL

0.5 L - 1.5 L fluid intake in the 24 hours prior to NPO status for surgery

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

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

Other: Oral water and clear liquids

Interventions

Oral water and clear liquids OTHER

Measured oral intake of fluids prior to tonsillectomy

Also known as: Oral Hydration

High fluid intake; Low fluid intake; Medium fluid intake

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead

MeSH Terms

Conditions

Surgical Wound; Pain, Postoperative; Agnosia

Interventions

Water

Condition Hierarchy (Ancestors)

Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Matthew Farrugia, DO

  Beaumont Health - Farmington Hills

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director, Otolaryngology Head and Neck Residency Program

Model Details: 3 group parallel comparison, non-blinded, interventional

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 19, 2022
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 4, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share