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Completed

NCT Number: NCT00390312

Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction

This study involves approximately 200 patients designed to evaluate the efficacy and safety of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction.

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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Third Molar Extraction

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Diagnosis and Main Criteria for Inclusion: Dental outpatients undergoing the removal of 3 or more third molars (2 of which were required to be mandibular and both must be bony impacted third molars).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female 18-40 years of age
  • Surgical extraction of at least three or more third molars (two must be mandibular and both must be bony impacted third molars)
  • Moderate or severe pain within 6 hours of completion of surgery

Exclusion criteria

  • Other oral surgical procedures during the same session except the removal of supernumerary third molars
  • Evidence of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety
  • Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated
  • Allergy to shellfish

Additional Inclusion/Exclusion Criteria May Apply

Treatment and study plan

Intranasal placebo

Drug

Intranasal placebo

Intranasal Morphine 15 mg

Drug

Intranasal Morphine 15 mg

Immediate Release Oral Morphine 60 mg

Drug

Immediate Release Oral Morphine 60 mg

intravenous morphine

Drug

Intravenous morphine 7.5 mg

Intranasal morphine 7.5 mg

Drug

Intranasal morphine 7.5 mg

oral placebo

Drug

Oral placebo

Intravenous placebo

Drug

Intravenous placebo

Primary outcomes

  1. Total pain relief (TOTPAR) at the 0-2 hour time interval calculated as the time-weighted sum of the Pain Relief (PR) scores for the time interval 0-2 hours

    Time frame: 2 hours

Secondary outcomes

  1. Other measures of pain relief

    Time frame: Several time points

Sponsors and collaborators

Lead sponsor

Javelin Pharmaceuticals

Industry

Registry information

Official study title

Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Single Dose Comparison of Analgesic Efficacy and Safety of Intranasal Morphine, Immediate Release Oral Morphine, Intravenous Morphine and Placebo in Postsurgical Dental Pain

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Oct 19, 2006
Registry last updated
Jan 4, 2008

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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