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Completed

NCT Number: NCT01082081

Post-operative Dental Pain Study Comparing Analgesic Efficacy

GlaxoSmithKline will be conducting this trial to compare analgesics efficacy of paracetamol 1000mg vs 500mg . The post-surgical dental pain model will be used to evaluate the analgesic efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The duration of the entire study will be approximately 16 weeks. Each subject will have to come to the clinic for three visits (Screening, Treatment and Follow up visits).

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Key information

Conditions

Post-surgical Dental Pain Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

PPD Dental Clinic, Austin, Texas, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects aged 18-45 years with moderate-to-severe dental pain assessed by verbal rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a visual analogue scale (VAS) following surgical removal of third molars, of which at least one has to be a mandibular partially bony or full bony impaction.

Treatment and study plan

Paracetamol 1000 mg

Drug

Paracetamol 1000 mg

Paracetamol 500 mg

Drug

Paracetamol 500 mg

Placebo

Drug

Placebo

Primary outcomes

  1. Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)

    Time frame: Every two hours from baseline to 6 hours post dose

    SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]

Secondary outcomes

  1. Time to Confirmed First Perceptible Pain Relief

    Time frame: Baseline to 6 hours post dose

    Participants recorded the time to first perceptible relief by starting the first stopwatch at the time of dosing and stopping it when he/she experienced the first perceptible pain relief. The first perceptible pain relief was confirmed if the participant also stopped the second stopwatch indicating meaningful relief.

  2. Time to Onset of Meaningful Pain Relief

    Time frame: Baseline to 6 hours post dose

    Participants evaluated the time to meaningful relief by stopping a second stopwatch when they first began to experience meaningful relief.

  3. Time to Start Using Rescue Medication

    Time frame: Baseline to 6 hours post dose

    Median time of use of rescue medication by participants was calculated.

  4. Percentage of Participants Who Took Rescue Medication Within 2 Hours

    Time frame: Baseline to 2 hours post dose

    Percentage of participants who received rescue medication within 2 hours

  5. Percentage of Participants Who Took Rescue Medication During 2 to 6 Hours

    Time frame: Within 2 to 6 hours post dose

    Percentage of participants who took rescue medication during 2 to 6 hours

  6. SPRID at 2 Hours

    Time frame: Every two hours from baseline to 2 hours post dose

    SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -1.8 (least pain relief) to 12.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]

  7. SPRID at 4 Hours

    Time frame: Every two hours from baseline to 4 hours post dose

    SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -3.8 (least pain relief) to 26.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline [pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale [0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief]

  8. Total Pain Relief (TOTPAR) at 2 Hours

    Time frame: Every two hours from baseline to 2 hours post dose

    TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Higher score indicated greater pain relief.

    TOTPARt = ∑PR x (timet - timet-1).

    PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief].

  9. TOTPAR at 4 Hours

    Time frame: Every two hours from baseline to 4 hours post dose

    TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Higher score indicated greater pain relief.

    TOTPARt = ∑PR x (timet - timet-1).

    PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief].

  10. TOTPAR at 6 Hours

    Time frame: Every two hours from baseline to 6 hours post dose

    TOTPAR was calculated as sum of products of pain relief (PR) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Higher score indicated greater pain relief.

    TOTPARt = ∑PR x (timet - timet-1).

    PR score was assessed at each of the above time-points based on a 5-point categorical scale [0-no relief, 1-little relief, 2-meaningful relief, 3-a lot of relief, 4-complete relief].

  11. Sum of Pain Intensity Difference (SPID) Scores at 2 Hours

    Time frame: Every two hours from baseline to 2 hours post dose

    SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120. Positive and higher scores indicate greater reduction in pain.

    SPIDt = ∑PID x (timet - timet-1)

    Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.

    If the subject rated pain intensity as "2" or "3", pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline.

  12. SPID Scores at 4 Hours

    Time frame: Every two hours from baseline to 4 hours post dose

    SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240. Positive and higher scores indicate greater reduction in pain.

    SPIDt = ∑PID x (timet - timet-1)

    Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.

    If the subject rated pain intensity as "2" or "3", pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline.

  13. SPID Scores at 6 Hours

    Time frame: Every two hours from baseline to 6 hours post dose

    SPID was calculated as sum of products of Pain Intensity Differences (PID) at a given time-point (t) with the time-interval from that time-point to the previous time-point (t-1). The time-intervals used were 0-15, 15-30, 30-45, 45-60, 60-90, 90-120, 120-240, 240-300 and 300-360. Positive and higher scores indicate greater reduction in pain.

    SPIDt = ∑PID x (timet - timet-1)

    Pain Intensity was assessed at baseline and at each time-point based on a 4-point categorical Verbal Rating Scale (VRS) scale: 0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain.

    If the subject rated pain intensity as "2" or "3", pain was assessed using a 100 mm Visual Analog Scale (VAS) [0 (no pain), 100 (worst pain)]. VAS scores were converted into PID scores by subtracting them from pain scores taken at baseline.

  14. Participants Global Assessment to Response to Treatment (PGART)

    Time frame: Baseline to 6 hours post dose

    PGART was measured by a score in a scale from 0-4: 0- Poor; 1- Fair 2- Good; 3- Very Good; 4- Excellent.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Study to Compare the Analgesic Efficacy of Two Different Paracetamol Doses as Measured by Post-operative Dental Pain Relief

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 8, 2010
Registry last updated
May 13, 2015

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.

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