Controlled Trial to Determine Most Effective Post-Operative Analgesia After Third Molar Extraction

NCT06484439 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: NMCSD.2018.0014
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized clinical trial that will investigate which post-operative medications in conjunction with a multimodal analgesia approach can most effectively control post-operative pain and reduce opioid consumption.

Conditions

Pain, Post-operative; Third Molar; Oral Surgery; Pain, Acute

Outcome Measures

Primary Outcomes (4)

• Post operative pain control after third molar extraction

  All participants will complete a daily survey on the medications taken to relieve pain.

  Up to five days post operative procedure.

• Post operative opioid use after third molar extraction

  Daily survey will be used to assess the amount of post operative opioid us including dosage and frequency of use.

  Up to five days post operative procedure.

• Post operative pain assessment after third molar extraction

  Participants fill out daily for five days post operative procedure the Numeric Pain Rating Scale (NPRS). This is a ten point scale with 0 = No pain, 5 = Moderate pain, 10 = Worst possible pain. The higher the number is a worse outcome.

  Up to five days post operative procedure.

• Post operative quality of life assessment after third molar extraction

  Post operative quality of life was ascertained with the 10 point Likert scaled question, "What is your rating for your actual overall comfort?'. 1 = Very low overall comfort, 5 = Neither low or high overall comfort, 10 = Very high overall comfort. The higher the score means a better outcome. This question is part of the daily survey that participants filled out for five days post operative procedure.

  Up to five days after third molar extraction.

Study Arms (2)

Acetaminophen, Ibuprofen, Hydrocodone Control arm

ACTIVE COMPARATOR

The control arm will be 650 mg Acetaminophen PO scheduled q6h, 600mg Ibuprofen PO scheduled q6h and 5 mg Hydrocodone PO PRN q6h.

Drug: Acetaminophen; Drug: Ibuprofen; Drug: Hydrocodone

Ketorolac, Acetaminophen, Oxycodone Study arm

EXPERIMENTAL

The study arm will be 10 mg Ketorolac PO q6h, 650 mg Acetaminophen PO scheduled q6h, and 5 mg Oxycodone PO PRN q6h.

Drug: Ketorolac; Drug: Oxycodone; Drug: Acetaminophen

Interventions

Ketorolac DRUG

10 mg PO q 6h scheduled

Also known as: Toradol

Ketorolac, Acetaminophen, Oxycodone Study arm

Oxycodone DRUG

5 mg PO PRN

Also known as: Oxycontin

Ketorolac, Acetaminophen, Oxycodone Study arm

Acetaminophen DRUG

650 mg q 6h scheduled

Also known as: Tylenol

Acetaminophen, Ibuprofen, Hydrocodone Control arm; Ketorolac, Acetaminophen, Oxycodone Study arm

Ibuprofen DRUG

600 mg PO scheduled q6h

Also known as: Motrin

Acetaminophen, Ibuprofen, Hydrocodone Control arm

Hydrocodone DRUG

5 mg hydrocodone PO PRN q6h

Also known as: Vicodin

Acetaminophen, Ibuprofen, Hydrocodone Control arm

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female 18 years or older
• Scheduled for 3rd molar extraction (x4) with at least one mandibular 3rd molar impacted
• American Society of Anesthesiologists classification 1 or 2
• Able to provide consent, adhere to study schedule, complete study journal, and understand English

You may not qualify if:

• History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids
• Contraindication to lidocaine, epinephrine, bupivacaine, or hydrocodone
• Significant drug allergy history
• Currently pregnant or nursing at time of study or within 1 month of drug administration
• Severe renal or hepatic impairment, significant cardiovascular disease; migraines, frequent headaches.
• Use of any of the following medication within 1 month of EXPAREL infiltration or if the medications are being given to control pain: Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Nonadrenaline Reuptake Inhibitors (SNRIs), gabapentin, pregabalin, or duloxetine.
• Current use of systemic glucocorticosteroids within 1 month of enrollment in the study
• No concurrent surgical procedures within 2 weeks before or after 3rd molar extractions

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Interventions

Ketorolac; Ketorolac Tromethamine; Oxycodone; Acetaminophen; Ibuprofen; Hydrocodone; acetaminophen, hydrocodone drug combination

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Patrick T Morrell, DMD

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants will be randomly assigned to one of two groups. Each group will be given one of two post-operative medication regimens consisting of a combination of either (1) Acetaminophen (Tylenol), Oxycodone, and Ibuprofen (Motrin), or (2) Acetaminophen (Tylenol), Oxycodone, and Ketorolac (Toradol). This research study is a double blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: July 3, 2024
• Study Start: February 14, 2018
• Primary Completion: November 3, 2021
• Study Completion: December 1, 2021
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)