Efficacy Study of IV Ibuprofen vs IV Acetaminophen Post Surgical Extraction (Caldolor)
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|ClinicalTrials.gov Identifier: NCT02133326|
Recruitment Status : Unknown
Verified October 2016 by Tufts University School of Dental Medicine.
Recruitment status was: Active, not recruiting
First Posted : May 8, 2014
Last Update Posted : January 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Impacted Wisdom Teeth||Drug: Caldolor Drug: Ofirmev||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Assessment of Preemptive Analgesic Effect of Caldolor® vs. Ofirmev® on Third Molar Surgery: A Prospective, Randomized, Double-blinded Clinical Trial|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2017|
800 mg of Caldolor® will be infused at the rate of 5-7 minutes as per the manufacturer's guidelines or
Subject will be given Caldolor by IV prior to surgery.
Other Name: IV Ibuprofen
1000 mg of Ofirmev® will be infused at the rate of 15 minutes as per the manufacturer's guidelines.
Subject will be given Ofirmev prior to surgery.
Other Name: Acetaminophen
- 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:
- Prior to surgery
- Immediately after the subject wakes from anesthesia
- First onset of pain (typically 45 minutes-1.5 hours after procedure)
- 4 hours post-operative
- 24 hours post-operative
- 48 hours post-operative
- 72 hours post-operative
- Day 7 post-operative
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133326
|United States, Massachusetts|
|Tufts University School of Dental Medicine Department of Oral and Maxillofacial Surgery|
|Boston, Massachusetts, United States, 02111|
|Tufts University School of Dental Medicine|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Archana Viswanath, BDS,MS||Tufts University School of Dental Medicine|