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A Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery

This study has been completed.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01356225
First received: May 16, 2011
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

The purpose of this study is to evaluate the analgesic efficacy of a single intranasal (IN) administration of ketorolac after dental impaction surgery.


Condition Intervention Phase
Pain
Dental Impaction
Drug: Ketorolac tromethamine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel, Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Summed Pain Intensity Difference (SPID) [ Time Frame: 8 hours postdose ] [ Designated as safety issue: No ]
    Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. The PI values were obtained at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours following the first dose of study medication on Day 1. Pain intensity difference (PID) was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication. A summed PID (SPID) on the first postoperative day was calculated at 8 hours.


Secondary Outcome Measures:
  • Summed Pain Intensity Difference (SPID) [ Time Frame: 4 and 6 hours postdose ] [ Designated as safety issue: No ]
    Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. The PI values were obtained at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours following the first dose of study medication on Day 1. Pain intensity difference (PID) was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication. A summed PID (SPID) on the first postoperative day was calculated at 4 and 6 hours.

  • Total Pain Relief (TOTPAR) [ Time Frame: 4, 6, and 8 hours postdose ] [ Designated as safety issue: No ]
    Scores were obtained from the pain relief evaluations by taking a weighted sum of pain relief scores. Pain relief was measured at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours on a 5-point categorical scale where 0 = no pain relief, 1 = a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.

  • Pain intensity difference (PID) and pain relief scores [ Time Frame: Before receiving study drug (baseline), at 20 and 40 minutes, and at 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours postdose ] [ Designated as safety issue: No ]
    Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. PID was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication. Pain relief was measured on a 5-point categorical scale with 0 = no pain relief, 1 = a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief.

  • Peak PID scores [ Time Frame: 4, 6, and 8 hours postdose ] [ Designated as safety issue: No ]
    Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. PID was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication. Peak PID was defined as the maximum PID score.

  • Peak pain relief scores [ Time Frame: 4, 6, and 8 hours postdose ] [ Designated as safety issue: No ]
    Pain relief was measured on a 5-point categorical scale with 0 = no pain relief, 1 = a little pain relief, 2 = some pain relief, 3 = a lot of pain relief, and 4 = complete pain relief. Peak pain relief was defined as the maximum peak pain relief score.

  • Time to onset of perceptible pain and meaningful pain relief [ Time Frame: After study drug administration until perceptible and meaningful pain relief was felt (during the 8-hour postdose observation period) ] [ Designated as safety issue: No ]
    The onset of pain relief was measured by the subjects stopping stopwatches when perceptible and meaningful relief was felt.

  • Time to first use of rescue medication [ Time Frame: After study drug administration until rescue analgesic therapy was requested (during the 8-hour postdose observation period) ] [ Designated as safety issue: No ]
    Duration of analgesia represented by the time until rescue analgesic therapy was requested.

  • Proportion of subjects taking rescue medication [ Time Frame: During 8-hour postdose observation period ] [ Designated as safety issue: No ]
    Proportion of subjects taking rescue medication in either group during the 8-hour postdose observation period.

  • Global pain control [ Time Frame: At the end of the 8-hour observation period, or at the time the subject took rescue analgesic medication if prior to 8 hours ] [ Designated as safety issue: No ]
    The subject was asked the question "How was your pain control overall?" This evaluation was measured on a 5-point categorical scale with 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent.


Enrollment: 80
Study Start Date: February 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intranasal Ketorolac tromethamine Drug: Ketorolac tromethamine
30 mg Intranasal (2 x 100 uL of a 15% solution), single dose
Placebo Comparator: Intranasal placebo Drug: Placebo
IN placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women, age 18 years or older.
  • Body weight > or = to 100 pounds and < or = 300 pounds.
  • Women of childbearing potential must have a negative serum pregnancy test result prior to entry into the study.
  • Able to provide written informed consent.
  • At least moderate pain as determined by a PI score of > or = to 50 mm on a 100-mm VAS.
  • Willing and able to comply with all testing and requirements defined in the protocol.
  • Willing and able to complete the posttreatment visit.
  • Immediately prior to entering the study, surgical removal of 3 or 4 third molars (at least 1 mandibular partial bony or complete bony impaction).

Exclusion Criteria:

  • Allergy or sensitivity to ketorolac or EDTA.
  • Allergic reaction to aspirin or other NSAIDs.
  • Current upper respiratory tract infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with the assessment of adverse events (AEs).
  • Use of any IN product within 24 hours prior to study entry.
  • Clinically significant abnormality on screening laboratory tests.
  • History of cocaine use resulting in nasal mucosal damage.
  • Active peptic ulcer disease, recent (defined as within 6 months) history of peptic ulcer disease or gastrointestinal bleeding considered by the investigator to be clinically significant.
  • Advanced renal impairment (serum creatinine >1.5 mg/dL) or a risk for renal failure due to volume depletion.
  • A history of any other clinically significant medical problem, which in the opinion of the investigator would interfere with study participation.
  • Participation within 30 days of study entry or within 5 times the half- life, whichever is longer, in another investigational drug study.
  • Pregnancy or breastfeeding.
  • Extraction of teeth other than third molars during the surgical procedure; exceptions:(1) supernumerary third molars; (2) cases whereby extraction of a third molar requires the removal of an adjacent molar.
  • Previous participation in this study.
  • Use of any short-acting NSAID (such as aspirin or ibuprofen) or acetaminophen within 12 hours of surgery.
  • Use of longer-acting NSAIDs (such as naproxen sodium) within 48 hours of surgery or piroxicam within 7 days of surgery.
  • Use of steroids (other than oral contraceptives) within 72 hours of surgery.
  • Use of mood-altering drugs, such a cannabis or alcohol, within 12 hours of surgery.
  • Surgical anesthesia including narcotic agents except fentanyl. Short-acting anesthetics, both DEA scheduled and unscheduled, were allowed. Naloxone in any form was not permitted.
  • Use of any other medication within 24 hours prior to surgery that, in the opinion of the investigator, could confound the subject's efficacy assessments (eg, sedatives, tranquilizers, MAO inhibitors, phenothiazines).
  • Consumption of any caffeine-containing products within 4 hours of surgery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356225

Locations
United States, Texas
Austin Oral Surgery - PPD Development
Austin, Texas, United States
Sponsors and Collaborators
Luitpold Pharmaceuticals
Investigators
Study Chair: Lincoln Bynum, MD GloboMax (ICON plc)
  More Information

No publications provided

Responsible Party: David Bregman, M.D., Ph.D., Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01356225     History of Changes
Other Study ID Numbers: ROX 2003-05
Study First Received: May 16, 2011
Last Updated: May 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Luitpold Pharmaceuticals:
pain following dental impaction surgery

Additional relevant MeSH terms:
Fecal Impaction
Tooth, Impacted
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Intestinal Obstruction
Stomatognathic Diseases
Tooth Diseases
Ketorolac
Ketorolac Tromethamine
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014