Skip to main content
OpenTrials
Completed

NCT Number: NCT01115673

To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery

The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

About this study

This trial is to assess the relative efficacy of acetaminophen 1000 mg versus acetaminophen 650 mg over a six-hour period, in subjects experiencing at least moderate post-operative dental pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must be at least 16 and less than 51 years of age
  • Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
  • Must have up to four of their back teeth (third-molars) pulled

Exclusion criteria

  • Cannot be allergic to acetaminophen (Tylenol)
  • Cannot be pregnant (or planning to be pregnant) or nursing a baby
  • Cannot have any other medical conditions that the investigator determines might compromise your safety or the study results

Treatment and study plan

Acetaminophen

Drug

Acetaminophen Caplet - single dose

Other names: Tylenol

Placebo Control

Drug

0 mg Caplet - single dose

Other names: Control

Primary outcomes

  1. Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)

    Time frame: 6 Hours

    Weighted Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief. For SPRID6, the total possible minimum value is -300 (worst) and the total possible maximum value is 1200 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.

Secondary outcomes

  1. Sum of Pain Intensity Difference Over Six Hours (SPID6)

    Time frame: 6 Hours

    Weighted Sum of the Pain Intensity Difference from Baseline Over Six Hours (SPID6) - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain. The total possible minimum value is -300 (worst) and the total possible maximum value is 600 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.

  2. Sum of Pain Relief Scores Over Six Hours (TOTPAR6)

    Time frame: 6 Hours

    Weighted Sum of the Pain Relief Scores Over Six Hours (TOTPAR6) - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief. The total possible minimum value is 0 (worst) and the total possible maximum value is 600 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.

  3. Pain Intensity Difference (PID) at 15 Minutes

    Time frame: 15 Minutes

    Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.

  4. Pain Intensity Difference (PID) at 30 Minutes

    Time frame: 30 Minutes

    Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.

  5. Pain Intensity Difference (PID) at 45 Minutes

    Time frame: 45 Minutes

    Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.

  6. Pain Intensity Difference (PID) at 60 Minutes

    Time frame: 60 Minutes

    Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.

  7. Pain Intensity Difference (PID) at 75 Minutes

    Time frame: 75 Minutes

    Pain Intensity Difference (PID) from Baseline at Each Assessment Time Point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.

  8. Pain Intensity Difference (PID) at 90 Minutes

    Time frame: 90 Minutes

    Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.

  9. Pain Intensity Difference (PID) at 120 Minutes

    Time frame: 120 Minutes

    Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.

  10. Pain Intensity Difference (PID) at 180 Minutes

    Time frame: 180 Minutes

    Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.

  11. Pain Intensity Difference (PID) at 240 Minutes

    Time frame: 240 Minutes

    Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.

  12. Pain Intensity Difference (PID) at 300 Minutes

    Time frame: 300 Minutes

    Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.

  13. Pain Intensity Difference (PID) at 360 Minutes

    Time frame: 360 Minutes

    Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.

  14. Pain Relief (PAR) Scores at 15 Minutes

    Time frame: 15 Minutes

    Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100

  15. Pain Relief (PAR) Scores at 30 Minutes

    Time frame: 30 Minutes

    Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100

  16. Pain Relief (PAR) Scores at 45 Minutes

    Time frame: 45 Minutes

    Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100

  17. Pain Relief (PAR) Scores at 60 Minutes

    Time frame: 60 Minutes

    Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100

  18. Pain Relief (PAR) Scores at 75 Minutes

    Time frame: 75 Minutes

    Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100

  19. Pain Relief (PAR) Scores at 90 Minutes

    Time frame: 90 Minutes

    Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100

  20. Pain Relief (PAR) Scores at 120 Minutes

    Time frame: 120 Minutes

    Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100

  21. Pain Relief (PAR) Scores at 180 Minutes

    Time frame: 180 Minutes

    Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100

  22. Pain Relief (PAR) Scores at 240 Minutes

    Time frame: 240 Minutes

    Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100

  23. Pain Relief (PAR) Scores at 300 Minutes

    Time frame: 300 Minutes

    Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100

  24. Pain Relief (PAR) Scores at 360 Minutes

    Time frame: 360 Minutes

    Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100

  25. Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes

    Time frame: 15 Minutes

    Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief

  26. Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes

    Time frame: 30 Minutes

    Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief

  27. Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes

    Time frame: 45 Minutes

    Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief

  28. Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes

    Time frame: 60 Minutes

    Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief

  29. Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes

    Time frame: 75 Minutes

    Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief

  30. Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes

    Time frame: 90 Minutes

    Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief

  31. Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes

    Time frame: 120 Minutes

    Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief

  32. Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes

    Time frame: 180 Minutes

    Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief

  33. Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes

    Time frame: 240 Minutes

    Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief

  34. Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes

    Time frame: 300 Minutes

    Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief

  35. Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes

    Time frame: 360 Minutes

    Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief

  36. Time to Meaningful Pain Relief

    Time frame: within 6 Hours

    Minutes until meaningful pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.

  37. Time to Confirmed Perceptible Pain Relief

    Time frame: within 6 Hours

    Minutes until confirmed perceptible pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relieving effect whatsoever of the drug, that was when they first felt any pain relief. It did not necessarily mean they felt completely better, although they might have, but when they first felt any difference in the pain.

  38. Duration of Analgesia - Time to Rescue

    Time frame: within 6 Hours

    Minutes until rescue medication was given.

  39. Rescue Rates Through Four Hours

    Time frame: through 4 Hours

    Percentage of subjects using rescue medication.

  40. Rescue Rates Through Six Hours

    Time frame: through 6 Hours

    Percentage of subjects using rescue medication.

  41. Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score

    Time frame: 6 Hours

    Percentage of Subjects with >50% of the Maximum Possible TOTPAR6 Score - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 600 so >50% is >300 out of 600

  42. Patient Global Evaluation

    Time frame: 6 Hours

    Patient Assessment of the Pain Medication - Number of Subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent

Sponsors and collaborators

Lead sponsor

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Industry

Registry information

Official study title

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Safety and Efficacy Study of Acetaminophen 1000 mg and Acetaminophen 650 mg in Post Operative Dental Pain

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 4, 2010
Registry last updated
May 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.