NCT02133326

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
67

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2014

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 20, 2017

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

September 17, 2013

Last Update Submit

January 19, 2017

Conditions

Impacted Wisdom Teeth

Keywords

AnalgesiaThird Molar ExtractionIbuprofenAcetaminophenPain MedicineNonsteroidalAnti-inflammatory

Outcome Measures

Primary Outcomes (1)

  • Efficacy of IV ibuprofen for post-op pain.

    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 Outcomes (1)

  • Pain medication consumption

    Post 3rd molar extraction

Study Arms (2)

Caldolor

EXPERIMENTAL

800 mg of Caldolor® will be infused at the rate of 5-7 minutes as per the manufacturer's guidelines or

Drug: Caldolor

Ofirmev

EXPERIMENTAL

1000 mg of Ofirmev® will be infused at the rate of 15 minutes as per the manufacturer's guidelines.

Drug: Ofirmev

Interventions

CaldolorDRUG

Subject will be given Caldolor by IV prior to surgery.

Also known as: IV Ibuprofen
Caldolor
OfirmevDRUG

Subject will be given Ofirmev prior to surgery.

Also known as: Acetaminophen
Ofirmev

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Full bony: The entire tooth is below the level of the alveolar bone.
  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tufts University School of Dental Medicine Department of Oral and Maxillofacial Surgery

Boston, Massachusetts, 02111, United States

Location

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

Related Publications (7)

  • Hargreaves KM, Troullos ES, Dionne RA. Pharmacologic rationale for the treatment of acute pain. Dent Clin North Am. 1987 Oct;31(4):675-94.

    PMID: 3319716BACKGROUND

  • Dionne RA, Khan AA, Gordon SM. Analgesia and COX-2 inhibition. Clin Exp Rheumatol. 2001 Nov-Dec;19(6 Suppl 25):S63-70.

    PMID: 11695255BACKGROUND

  • Gordon SM, Brahim JS, Rowan J, Kent A, Dionne RA. Peripheral prostanoid levels and nonsteroidal anti-inflammatory drug analgesia: replicate clinical trials in a tissue injury model. Clin Pharmacol Ther. 2002 Aug;72(2):175-83. doi: 10.1067/mcp.2002.126501.

    PMID: 12189364BACKGROUND

  • Ridgway D. Analgesics for acute pain: Meeting the United States Food and Drug Administration's requirements for proof of efficacy. Clin J Pain. 2004 May-Jun;20(3):123-32. doi: 10.1097/00002508-200405000-00001.

    PMID: 15100587BACKGROUND

  • Southworth S, Peters J, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain. Clin Ther. 2009 Sep;31(9):1922-35. doi: 10.1016/j.clinthera.2009.08.026.

    PMID: 19843482BACKGROUND

  • Arici S, Gurbet A, Turker G, Yavascaoglu B, Sahin S. Preemptive analgesic effects of intravenous paracetamol in total abdominal hysterectomy. Agri. 2009 Apr;21(2):54-61.

    PMID: 19562533BACKGROUND

  • Borisov, D Preemptive analgesia with paracetamol in postoperative analgesia for abdominal surgery: 14AP5-2 European Journal of Anaesthesiology: June 2007 - Volume 24 - Issue - p 179

    BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

IbuprofenAcetaminophen

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Archana Viswanath, BDS,MS

    Tufts University School of Dental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2013

First Posted

May 8, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 20, 2017

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)