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
Protocol serial number	NL0408
Sponsor	Reckitt Benckiser Healthcare (UK)
Funder	Reckitt Benckiser Healthcare (UK)

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

SCIREX Research Center/ Premier Research Group
3200 Red River
Suite 300
Austin
TX 78705
United States of America

Study information

Primary study design	Interventional
Study design	Randomised double blind placebo controlled single dose modified factorial design study using the dental impaction pain model
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Sum of Pain Relief and Pain Intensity Differences from 0-8 hours (SPRID 0-8)
Key secondary outcome measure(s)	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
Completion date	15/02/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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.