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OpenTrials
Completed

NCT Number: NCT00488787

Safety and Efficacy of Intranasal Ketamine for the Treatment of Postoperative Dental Pain

Once patients' postoperative pain intensity reaches a moderate-to-severe level, they are randomized to receive intranasal ketamine or placebo. Patients remain in the study unit for 3 hours post administration and assess pain intensity and pain relief throughout the 3 hour postoperative period.

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Key information

Conditions

Pain, Postoperative Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy patients at least 16 years of age requiring two or more third molar extractions

Exclusion criteria

  • Less than 16 years old
  • Other exclusion criteria may apply

Treatment and study plan

Intranasal ketamine

Drug

low dose

Placebo

Drug

placebo

Primary outcomes

  1. total pain relief over 0-3 hours following dosing

    Time frame: 3 hours

Secondary outcomes

  1. other pain assessments

    Time frame: 3 hours

Sponsors and collaborators

Lead sponsor

Javelin Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Efficacy of 10 mg, 30 mg, and 50 mg of Transnasal Ketamine Hydrochloride (PMI-100) for the Treatment of Postoperative Dental Pain

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Jun 20, 2007
Registry last updated
Feb 7, 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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