Efficacy Study of IV Ibuprofen vs IV Acetaminophen Post Surgical Extraction (Caldolor)

January 19, 2017 updated by: Tufts University School of Dental Medicine

Assessment of Preemptive Analgesic Effect of Caldolor® vs. Ofirmev® on Third Molar Surgery: A Prospective, Randomized, Double-blinded Clinical Trial

This study will compare how effective a single dose of an intravenous (IV) ibuprofen is when compared to single dose of IV acetaminophen in reducing pain. We will administer this study medication thirty minutes prior to removal of wisdom teeth. We want to see if administering these drugs prior to surgery may reduce post-operative pain.

Administration of nonsteroidal anti-inflammatory drug before the onset of inflammation during surgery will reduce postoperative pain following third molar extraction when compared to the acetaminophen group. Subjects receiving nonsteroidal anti-inflammatory drug will consume less opioid medications compared to those receiving preemptive acetaminophen.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The surgical removal of third molars is a common surgical procedure performed in dentistry. Surgery to extract an impacted third molar can be due to various reasons such as infection, caries, pain, cyst or tumor formation, or to facilitate orthodontic treatment. Both clinicians and patients are concerned with the postoperative pain following surgery.

Rationale for model selection The oral surgery model is well-suited for the measurement of acute pain.The model has been shown to be sensitive to the effects of analgesic drugs and is useful for examining peripheral biochemical measures of drugs in vivo.This model is recommended by the US Food and Drug Administration because patients are usually healthy without complicating medical conditions and most patients have pain for a short, predictable period after surgery.

Rationale for drug selection Pain from the surgical incision and tissue manipulation associated with the surgical procedure is instigated immediately. This gives way to inflammatory pain that follows inflammatory cell recruitment to the injured area within the course of several hours. Inflammatory pain generally continues for several days, depending on the nature of the surgical procedure. As a consequence of tissue damage and release of neurogenic inflammatory mediators, there is activation of specific receptors and pathways that can contribute to central sensitization and development of hyperalgesia and persistent pain. While various pharmacological strategies, including the use of opioids, provide adequate attenuation of pain, their use is associated with undesirable side effects, drug interactions, pharmacokinetic variability, and often inadequate dosing, all of which can lead to ineffective analgesia and prolonged suffering. Opioids do not interrupt the inflammatory component of pain.

The study drug Caldolor® is an intravenous formulation of ibuprofen which was approved by the FDA in June 2009. Caldolor® is the first injectable product available in the United States for the treatment of pain and fever. This is the first study in dentistry evaluating the use of Caldolor® as a preemptive analgesia. Southworth et al and colleagues randomized 406 patients undergoing elective single-site orthopedic or abdominal surgery to 400 mg intravenous (IV) Caldolor, 800 mg IV Caldolor, or placebo. The results showed that patients in the 800 mg group had a 25.6% lower median morphine use (P = .026) over the first 24 hours of treatment than the placebo group. Patients in the 400 mg group did not have a lower use of morphine, but both the 400 and 800 mg groups reported less pain at rest and with movement than with placebo.

The comparator group Ofirmev® is intravenous acetaminophen and was recently approved by the FDA for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever. In a study conducted for total abdominal hysterectomy, preemptive IV paracetamol (acetaminophen) 1 g provided good quality postoperative analgesia, with decreased consumption of morphine and minimal side effects. Studies have showed that the use of 1 g of paracetamol as a single intravenous preemptive dose in abdominal surgery with perioperative epidural analgesia did not reduce the analgesic consumption and the intensity of pain in the postoperative period.

Use of Pain Scale VAS Pain Scale Score: The primary end point is the clinical report of pain. Pain intensity will be assessed using a 100 mm VAS with anchors of "no pain" and "worst pain imaginable" and a 4-point category scale ("none", "mild", "moderate", and "severe") once pre-operatively and over the post-operative observation period at 30-minute intervals during the post- surgical time. The category scale is included for purposes of obtaining a patient-reported assignment of moderate pain (definition of clinically significant pain), and for computing the cut-offs for pain sensitivity.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts University School of Dental Medicine
      • Boston, Massachusetts, United States, 02111
        • Tufts University School of Dental Medicine Department of Oral and Maxillofacial Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients should be at least 18 years old.

  • Subjects for whom a decision has been made to extract at least two third molars classified as full or partially bony impacted in the mandible and/or maxilla in an outpatient setting under ambulatory general anesthesia.

    1. Full bony: The entire tooth is below the level of the alveolar bone.
    2. Partial bony: A portion of the height of the contour of the tooth is below the level of the alveolar bone.
  • Subjects must be physically able to tolerate conventional surgical procedures (ASA I/II)
  • Subjects must agree to follow the study protocol.

Exclusion Criteria:

  • Subjects who are known to be pregnant or think they may be pregnant. (Female patients will be asked to perform a pregnancy test on the day of surgery to confirm they meet study criteria)
  • Subjects with known allergy and/or contradiction to ibuprofen and acetaminophen.
  • Subjects with history of alcohol or drug abuse (self-reported).
  • Subjects who are currently receiving any anti-inflammatory or pain medication or they suffer from a chronic pain condition.
  • Subjects that refuse to participate in the follow up protocol including completing pain diaries.
  • Actively infected third molars with swelling, trismus, and/or purulent discharge.
  • Subjects for whom the lidocaine with epinephrine is contraindicated (e.g., allergy to drug).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caldolor
800 mg of Caldolor® will be infused at the rate of 5-7 minutes as per the manufacturer's guidelines or
Drug: Caldolor
Subject will be given Caldolor by IV prior to surgery.
Other Names:
  • IV Ibuprofen
Experimental: Ofirmev
1000 mg of Ofirmev® will be infused at the rate of 15 minutes as per the manufacturer's guidelines.
Drug: Ofirmev
Subject will be given Ofirmev prior to surgery.
Other Names:
  • Acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of IV ibuprofen for post-op pain.
Time Frame: 7 days post-operative

To determine the efficacy of a single dose of intravenous ibuprofen administered over 5-10 minutes for the preemptive treatment of postoperative pain following third molar extraction.The post operative pain intensity will be measured using (Visual Analog Scale, VAS). A total of 9 pain ratings will be obtained:

  1. Prior to surgery
  2. Immediately after the subject wakes from anesthesia
  3. First onset of pain (typically 45 minutes-1.5 hours after procedure)
  4. 4 hours post-operative
  5. 24 hours post-operative
  6. 48 hours post-operative
  7. 72 hours post-operative
  8. Day 7 post-operative
7 days post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain medication consumption
Time Frame: Post 3rd molar extraction
To determine any difference in the percentage of pain medications consumed post operatively in both the groups.
Post 3rd molar extraction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts University School of Dental Medicine

Investigators

  • Principal Investigator: Archana Viswanath, BDS,MS, Tufts University School of Dental Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

September 17, 2013

First Submitted That Met QC Criteria

May 6, 2014

First Posted (Estimate)

May 8, 2014

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Caldolor vs. Orfimev Clinical

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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