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

NCT01356225 | Completed Phase 2

• 1 other identifier: ROX 2003-05
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Dental Impaction

Keywords

pain following dental impaction surgery

Outcome Measures

Primary Outcomes (1)

• Summed Pain Intensity Difference (SPID)

  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.

  8 hours postdose

Secondary Outcomes (9)

• Summed Pain Intensity Difference (SPID)

  4 and 6 hours postdose

• Total Pain Relief (TOTPAR)

  4, 6, and 8 hours postdose

• Pain intensity difference (PID) and pain relief scores

  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

• Peak PID score

  4, 6, and 8 hours postdose

• Peak pain relief scores

  4, 6, and 8 hours postdose

Study Arms (2)

Intranasal Ketorolac tromethamine

EXPERIMENTAL

Drug: Ketorolac tromethamine

Intranasal placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ketorolac tromethamine DRUG

30 mg Intranasal (2 x 100 uL of a 15% solution), single dose

Intranasal Ketorolac tromethamine

Placebo DRUG

IN placebo

Intranasal placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egalet Ltd: lead

Study Sites (1)

Austin Oral Surgery - PPD Development

Austin, Texas, United States

Location

MeSH Terms

Conditions

Pain; Tooth, Impacted

Interventions

Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lincoln Bynum, MD

  GloboMax (ICON plc)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 19, 2011
• Study Start: February 1, 2004
• Primary Completion: March 1, 2004
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

US (1)