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Completed

NCT Number: NCT00266786

Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery

Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile.

Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing.

Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.

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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–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Waikato Clinical Research, Hamilton, New Zealand

Loading trial locations.

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 through 64 years
  • Major abdominal surgery
  • Body weight ≥ 100 and ≤ 300 pounds
  • Negative serum pregnancy test
  • Pain intensity score at least 40 (moderate pain) on 100 mm visual analog scale
  • Minimum 48 hour hospital stay and 5 day maximum stay
  • Able to provide written informed consent
  • Willing and able to comply with all testing requirements of the protocol

Exclusion criteria

  • Allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (EDTA)
  • Allergy or significant reaction to opioids
  • Allergic reaction to aspirin or other nonsteroidal anti-inflammatory drug (NSAIDs)
  • Current upper respiratory tract infection or other respiratory tract condition that could interfere with absorption of the nasal spray or adverse event assessment
  • Use of any intranasal product in past 24 hours
  • Clinically significant abnormality on screening lab tests
  • History of cocaine use
  • Active peptic ulcer disease or significant history of peptic ulcer disease or gastrointestinal bleeding
  • Advanced renal impairment or risk for renal failure
  • History of other medical problems that could interfere with the study participation
  • Pregnancy or breastfeeding
  • Participation in another investigational study within past 30 days

Treatment and study plan

Intranasal Ketorolac Tromethamine

Drug

Intranasal at 30mg

Intranasal placebo

Drug

Intranasal Placebo

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. Pain intensity difference scores

    Time frame: Prior to receiving study drug and at 20, 40, and 60 minutes, and 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours after the first dose, then prior to each dose up to 72 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. 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.

  2. Quality of analgesia

    Time frame: Prior to receiving study drug and at 20, 40, and 60 minutes, and 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours after the first dose, then prior to each dose up to 72 hours

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

  3. 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.

  4. Morphine sulfate consumption at 24, 48, and 72 hours

    Time frame: 24, 48, and 72 hours after drug administration

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 Following Major Abdominal Surgery

Important dates

Study start
2005
Primary completion
2007
First posted
Dec 19, 2005
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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