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NCT Number: NCT01347853

Safety and Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain

This was a randomized, double-blind, placebo-controlled study in subjects who underwent major surgery. Each subject's study participation consisted of a screening visit and a treatment period of up to 5 days. Following surgery (Day 0), subjects were randomly assigned to receive intranasal ketorolac 30 mg or intranasal placebo when the pain intensity (PI) rating equaled at least 40 mm on a 100-mm visual analog scale (VAS). Subjects received study drug every 8 hours for 48 hours and then 3 times daily for up to 5 calendar days in total; the frequency of dosing could be reduced after 48 hours. Starting at the time of the first dose of study drug and continuing for the first 48 hours after surgery, the subjects had access to morphine sulfate (MS) administered via patient controlled analgesia (PCA). After PCA was no longer required, backup pain relief was provided by another standard nonsteroidal anti-inflammatory drug (non-NSAID) analgesic regimen. If the subjects were discharged before postoperative Day 4, they could self-medicate at home through postoperative Day 4. A safety follow-up evaluation was conducted by telephone approximately 14 days after the end of dosing in a subset of subjects (n = 60).

The primary objective was to evaluate the analgesic efficacy of multiple intranasal doses of ketorolac administered for up to 5 days. The secondary objective was to evaluate the safety and tolerability of this dosing regimen.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Waikato Clinical Research

Hamilton, New Zealand

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men or women, age 18 years or older.
  • Body weight > or = to 100 pounds and < or = to 300 pounds.
  • Women of childbearing potential must have a negative serum pregnancy test result.
  • Able to provide written informed consent.
  • At least moderate pain as determined by a PI score of > or = to 40 mm on a 100-mm VAS.
  • Expected to remain in the hospital for at least 48 hours with the possibility of remaining for 5 days.
  • Willing and able to comply with all testing and requirements defined in the protocol.
  • Willing and able to complete the post-treatment visit.

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.
  • Use of any intranasal (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.
  • Allergy or significant reaction to opioids.
  • Pregnancy or breastfeeding.
  • Previous participation in this study.

Treatment and study plan

Ketorolac Tromethamine

Drug

30 mg intranasal post-surgery for up to 5 days total

Placebo

Drug

Intranasal post-surgery for up to 5 days total

Primary outcomes

  1. The Summed Pain Intensity Difference (SPID) on Day 1

    Time frame: 6 hours after drug administration

    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 every hour 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 6 hours.

Secondary outcomes

  1. Morphine sulfate consumption at 24 hours and 48 hours

    Time frame: 24 hours and 48 hours after drug administration

  2. Hourly Pain Intensity Difference (PID) scores.

    Time frame: Hourly following the first dose of study medication up to 8 hours

    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 during the first 8 hours following the first dose of study medication on Day 1. 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.

  3. Quality of analgesia

    Time frame: First dose of study medication on Day 1 to the first dose of MS by PCA

    Quality of analgesia was assessed on a 5-point categorical scale with 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent.

  4. Global assessment of pain control

    Time frame: 8 hours following first dose of study medication

    A global evaluation of pain control was conducted once daily at bedtime using a 5-point categorical scale on which 0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent.

  5. Onset and duration of pain relief

    Time frame: 8 hours following first dose of study medication

    The onset of pain relief was defined as the time when the stopwatch was stopped to indicate "meaningful" pain relief. Peak PID was calculated. Duration of analgesia was defined as the time from the first dose of study medication on Day 1 to the first dose of MS by PCA.

Sponsors and collaborators

Lead sponsor

Egalet Ltd

Industry

Registry information

Official study title

A Phase 3, Double-blind, Randomized Study of the Safety, Tolerability, and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain

Important dates

Study start
2003
Primary completion
2005
Study completion
2007
First posted
May 4, 2011
Registry last updated
Feb 8, 2017

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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