Comparison of Advil® and Tylenol® Extra Strength, separately and in combination, to alleviate postoperative dental pain
| ISRCTN | ISRCTN86009231 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86009231 |
| Secondary identifying numbers | NL0408 |
- Submission date
- 09/06/2010
- Registration date
- 24/06/2010
- Last edited
- 31/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Stephen Daniels
Scientific
Scientific
SCIREX Research Center/ Premier Research Group
3200 Red River
Suite 300
Austin
TX 78705
United States of America
Study information
| Study design | Randomised double blind placebo controlled single dose modified factorial design study using the dental impaction pain model |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Comparing the analgesic efficacy of Advil® and Tylenol® Extra Strength, separately and in combination, in patients experiencing postoperative dental pain: A double blind, randomised, placebo controlled, parallel group trial with modified factorial design |
| Study objectives | The objective of this study was to compare the analgesic efficacy of Advil® tablets (200 or 400 mg ibuprofen) given concurrently with Tylenol® Extra Strength (ES) caplets (500 or 1000 mg acetaminophen [paracetamol]) to: 1) Advil tablets (400mg ibuprofen) alone; 2) Tylenol ES caplets (1000mg acetaminophen) alone; 3) Placebo among subjects experiencing moderate to severe postoperative dental impaction pain. Analgesic efficacy was measured in terms of total effect, peak effect, onset and duration of effect, and subjects overall assessment of the study medication. A secondary objective was to evaluate the tolerability (adverse event [AE] profile) of the combination of Advil tablets (200 or 400 mg ibuprofen) given concurrently with Tylenol Extra Strength (500 or 1000 acetaminophen) to the individual ingredients and to placebo. |
| Ethics approval(s) | Quorum Review (Seattle, WA) independent institutional review board (IRB) approved on the 8th of October 2004 |
| Health condition(s) or problem(s) studied | Dental Pain |
| Intervention | Subjects were randomly allocated to one of the 5 treatment groups: 1. 400mg Ibuprofen alone 2. 1000mg Acetaminophen alone 3. 400mg Ibuprofen plus 1000mg acetaminophen 4. 200mg Ibuprofen plus 500mg acetaminophen 5. Placebo |
| Intervention type | Other |
| Primary outcome measure | Sum of Pain Relief and Pain Intensity Differences from 0-8 hours (SPRID 0-8) |
| Secondary outcome measures | 1. Total Pain Relief from 0 to 8 hours (TOTPAR 0-8) 2. Sum of the Pain Intensity Differences from 0 to 8 hours (SPID 0-8) 3. Sum of the Pain Intensity Differences on the VAS scale from 0 to 8 hours (SPID VAS 0-8) 4. TOTPAR, SPID, SPRID, and SPID VAS from 0 to 4 hours (0-4) and 0 to 6 hours (0-6) 5. Individual pain relief (PR) readings at each time point from 15 minutes to 8 hours 6. Peak PR recorded during the 8-hour evaluation period 7. Individual PID at each time point from 15 minutes to 8 hours 8. Individual PID for the VAS scale (PID VAS) at each time point from 15 minutes to 8 hours 9. Peak PID and peak PID VAS recorded during the 8-hour evaluation period 10. First time at which the PID was at least 1 11. Time to first perceptible pain relief 12. Time to first confirmed perceptible pain relief 13. Time to first meaningful pain relief 14. Time to use of rescue medication 15. Time to pain half gone 16. Subjects overall (global) assessment |
| Overall study start date | 02/11/2004 |
| Completion date | 15/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Analysed: 234 |
| Total final enrolment | 234 |
| Key inclusion criteria | 1. Age: between the ages of 16 and 40 years of age 2. Sex: either male or female 3. Primary diagnosis: At least three impacted third molars (two of which must have been mandibular impacted molars) indicated for removal. Both mandibular impactions must have required bone removal, and there must have been a total score of 9 or greater on the impaction grading scale for the three or four impacted third molar 4. Baseline Pain Intensity: were experiencing postoperative pain of at least moderate based on the pain intensity categorical rating scale and a pain intensity VAS score of 50mm or greater on the 100mm VAS Scale 5. Consent: gave written informed consent. Subjects who were 16 or 17 years of age also required their parents or legal guardian to provide written informed consent in addition to their written assent |
| Key exclusion criteria | 1. Had a current history of significant disease deemed by the investigator to render the subject unsuitable for inclusion 2. Had any ongoing painful condition other than that associated with their third molar surgery 3. Had an ongoing condition that may have interfered with the absorption, distribution, metabolism or excretion of the study drug 4. Had a history of allergy (including angioedema, urticaria, bronchospasm and rhinitis) related to the treatment with ibuprofen, acetaminophen, aspirin, other NSAIDs or any other medication used in this study 5. A history of frequent peptic ulcers, duodenal ulcers or GI bleeding 6. A history of frequent dyspepsia, heartburn or indigestion 7. A history of migraine headaches within the past year 8. A history of psychotic illness, attempted suicide or neurosis 9. Those unable to refrain from smoking during their stay in the research centre 10. A positive history of drug or alcohol abuse within the past six months 11. Those who were taking any concomitant medication that might have confounded assessments of pain relief (PAR), such as: psychotropic drugs, antidepressants, sedative-hypnotics (other than those permitted for conscious sedation), or other analgesics taken within five times of their elimination half lives. Selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenalin reuptake inhibitors (SNRIs) were permitted if the subject had been on a stable dose for at least four weeks prior to visit 1 (screening) 12. Those who were unable, in the opinion of the investigator, to comply fully with the study requirements 13. Those previously randomised into this study 14. Those who had participated in a clinical trial in the previous 12 weeks. Twelve weeks (calculated from the time of last dosing in the prior trial to time of anticipated dosing in this trial) |
| Date of first enrolment | 02/11/2004 |
| Date of final enrolment | 15/02/2005 |
Locations
Countries of recruitment
- United States of America
Study participating centre
SCIREX Research Center/ Premier Research Group
Austin
TX 78705
United States of America
TX 78705
United States of America
Sponsor information
Reckitt Benckiser Healthcare (UK)
Industry
Industry
Dansom Lane
Hull
HU8 7DS
United Kingdom
"ROR" |
https://ror.org/01g87hr29 |
|---|
Funders
Funder type
Industry
Reckitt Benckiser Healthcare (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2010 | 31/10/2019 | Yes | No |
Editorial Notes
31/10/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
