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Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management

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ClinicalTrials.gov Identifier: NCT04059172
Recruitment Status : Not yet recruiting
First Posted : August 16, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The purpose of this study is to compare the effectiveness of a combined ibuprofen and acetaminophen regimen in controlling discomfort for 4 days after initial orthodontic appliance placement as compared to ibuprofen alone or a placebo. The hypothesis is that combined ibuprofen and acetaminophen therapy will effectively provide better pain control than ibuprofen alone or a placebo after orthodontic appliance placement.

Condition or disease Intervention/treatment Phase
Pain, Orofacial Drug: Ibuprofen 200 mg and acetaminphen 650 mg Drug: Ibuprofen 200 mg Drug: Placebo oral tablet Early Phase 1

Detailed Description:

Orthodontic pain is often reported for the first 4 days after the appliances are attached. This study will investigate two modes of pain management versus a placebo. Consented subjects will be randomly assigned to one of 3 groups: Group A, a combined and simultaneous therapy of 200 mg ibuprofen and 650 mg acetaminophen (3 pills total) taken orally at set time intervals (0 h, 6 h, 12 h, and 24h, 48h, 72h, and 96h); Group B, ibuprofen alone (200 mg) taken orally at same time intervals (1 ibuprofen and 2 placebo pills); Group C, placebo taken orally at the same time intervals (3 placebo pills).

The study will be blinded for the investigators, patients, and statisticians.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two investigational groups and a placebo group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Ibuprofen, acetaminophen and placebo tablets have been prepared to look identical by a pharmacy. The appropriate tablets are placed in a blister pack to be delivered to the study participant. The number of tablets are the same for each blister in all blister packs.

The study participant, care provider, investigators and the outcomes assessor are all blinded to the groups.

Primary Purpose: Treatment
Official Title: Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain of Initial Orthodontic Wire Insertion: a Randomized Controlled Trial
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ibuprofen
one 200 mg tablet of ibuprofen and 2 placebo tablets
Drug: Ibuprofen 200 mg

For morning appliance placement: dose #1 at approximately 9:00 a.m. as appointment starts; dose #2 6 hours later (3:00 p.m- or as soon after school and close to 3 pm as possible.); dose #3 another 6 hours later (9:00 p.m.); dose #4 the following morning upon waking (approximately 24 hours from start and patient will record the time), doses #5 through #7 will be taken every morning upon waking on the second, third, and fourth days, respectively.

For afternoon appliance placement: dose #1 at approximately 2:00 p.m. as appointment starts; dose #2 6 hours later (8:00 p.m.); dose #3 the following morning upon waking (approximately 12 hours later and patient will record the time); dose #4 6 hours later from dose #3 (approximately 24 hours from the initial dose) around 2:00 p.m. (or as soon after school as possible) doses #5 through #7 will be taken every afternoon at 2:00 p.m. on the second, third, and fourth days, respectively.


Experimental: Ibuprofen and acetaminophen
one 200 mg table of ibuprofen and two 325 mg tablets of acetaminophen
Drug: Ibuprofen 200 mg and acetaminphen 650 mg

For morning appliance placement: dose #1 at approximately 9:00 a.m. as appointment starts; dose #2 6 hours later (3:00 p.m- or as soon after school and close to 3 pm as possible.); dose #3 another 6 hours later (9:00 p.m.); dose #4 the following morning upon waking (approximately 24 hours from start and patient will record the time), doses #5 through #7 will be taken every morning upon waking on the second, third, and fourth days, respectively.

For afternoon appliance placement: dose #1 at approximately 2:00 p.m. as appointment starts; dose #2 6 hours later (8:00 p.m.); dose #3 the following morning upon waking (approximately 12 hours later and patient will record the time); dose #4 6 hours later from dose #3 (approximately 24 hours from the initial dose) around 2:00 p.m. (or as soon after school as possible) doses #5 through #7 will be taken every afternoon at 2:00 p.m. on the second, third, and fourth days, respectively.


Placebo Comparator: Placebo
3 tablets of tableting compounds with no active ingredients
Drug: Placebo oral tablet

For morning appliance placement: dose #1 at approximately 9:00 a.m. as appointment starts; dose #2 6 hours later (3:00 p.m- or as soon after school and close to 3 pm as possible.); dose #3 another 6 hours later (9:00 p.m.); dose #4 the following morning upon waking (approximately 24 hours from start and patient will record the time), doses #5 through #7 will be taken every morning upon waking on the second, third, and fourth days, respectively.

For afternoon appliance placement: dose #1 at approximately 2:00 p.m. as appointment starts; dose #2 6 hours later (8:00 p.m.); dose #3 the following morning upon waking (approximately 12 hours later and patient will record the time); dose #4 6 hours later from dose #3 (approximately 24 hours from the initial dose) around 2:00 p.m. (or as soon after school as possible) doses #5 through #7 will be taken every afternoon at 2:00 p.m. on the second, third, and fourth days, respectively.





Primary Outcome Measures :
  1. Change in visual analogue score (VAS) over time [ Time Frame: 0 hours, 6 hours, 12 hours, and 24 hours, 48 hours, 72 hours, and 96 hours after placement of appliances ]
    Primary outcomes with be the pain values recorded by subjects when chewing on the 100-mm VAS at set times.The VAS line for each time period will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right.


Secondary Outcome Measures :
  1. Dosing Compliance [ Time Frame: to be recorded at 0 hours, 6 hours, 12 hours, and 24 hours, 48 hours, 72 hours, and 96 hours after placement of appliances. ]
    The VAS containing booklet will ask the patient to record if he or she took all of the pills provided at each time point to monitor compliance. Additionally, the VAS containing booklet will ask the patient to record will ask if any additional medication was taken and if so, to name the additional medication and dosage.



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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • scheduled to begin comprehensive orthodontic treatment (banding/bonding of at least 10 teeth in 1 arch and archwire placement in at least 1 arch);
  • extractions, if required, performed at least 2 weeks before appliance and archwire placement;
  • healthy with no significant medical findings;
  • no prophylactic antibiotic coverage required;
  • currently not taking antibiotics or analgesics;
  • no contraindications to the use of acetaminophen or ibuprofen; and
  • minimum age of 12 years

Exclusion Criteria:

  • Under the age of 12 or over the age of 80,
  • prisoners,
  • pregnant women,
  • decisionally challenged individuals,
  • allergy to either medication,
  • history of kidney disease,
  • liver damage or disease,
  • alcoholism/use of 3 or more alcoholic drinks during study period,
  • use of blood thinners,
  • stomach ulcers or
  • stomach bleeding.

Information from the National Library of Medicine

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): NCT04059172


Contacts
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Contact: Clifton M Carey, PhD 3016399666 clifton.carey@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado, School of Dental Medicine
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver

Publications:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04059172     History of Changes
Other Study ID Numbers: 17-1449
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The IPD will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Facial Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action