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

Primary Purpose

Pain, Orofacial

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen 200 mg and acetaminphen 650 mg
Ibuprofen 200 mg
Placebo oral tablet
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Orofacial

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Colorado, School of Dental MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Ibuprofen

Ibuprofen and acetaminophen

Placebo

Arm Description

one 200 mg tablet of ibuprofen and 2 placebo tablets

one 200 mg table of ibuprofen and two 325 mg tablets of acetaminophen

3 tablets of tableting compounds with no active ingredients

Outcomes

Primary Outcome Measures

Change in visual analogue score (VAS) over time
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

Dosing Compliance
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.

Full Information

First Posted
August 7, 2019
Last Updated
May 13, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04059172
Brief Title
Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Orofacial

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Two investigational groups and a placebo group
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
375 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
one 200 mg tablet of ibuprofen and 2 placebo tablets
Arm Title
Ibuprofen and acetaminophen
Arm Type
Experimental
Arm Description
one 200 mg table of ibuprofen and two 325 mg tablets of acetaminophen
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
3 tablets of tableting compounds with no active ingredients
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 200 mg and acetaminphen 650 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 200 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
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 Measure Information:
Title
Change in visual analogue score (VAS) over time
Description
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.
Time Frame
0 hours, 6 hours, 12 hours, and 24 hours, 48 hours, 72 hours, and 96 hours after placement of appliances
Secondary Outcome Measure Information:
Title
Dosing Compliance
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clifton M Carey, PhD
Phone
3037241046
Email
clifton.carey@cuanschutz.edu
Facility Information:
Facility Name
University of Colorado, School of Dental Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clifton Carey, PhD
Phone
303-724-1046
Email
clifton.carey@ucdenver.edu
First Name & Middle Initial & Last Name & Degree
Craig Shellhart, DDS
Phone
3037246993
Email
craig.shellhaart@ucdenver.edu
First Name & Middle Initial & Last Name & Degree
Kyle Aten, DDS
First Name & Middle Initial & Last Name & Degree
Matthew Iritani, DDS

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The IPD will not be shared with other researchers.
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Efficacy of Combined Ibuprofen and Acetaminophen Therapy Versus Ibuprofen Alone Versus Placebo Alone for Pain Management

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