Trial | NCT00488787  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ketamine ...

  • Study Participants

    40
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.
Study Started
Mar 31
2001
Primary Completion
Apr 30
2001
Study Completion
Apr 30
2001
Last Update
Feb 07
2008
Estimate

Drug intranasal ketamine

low dose

Drug intranasal ketamine

medium dose

Drug intranasal ketamine

high dose

Drug placebo

placebo

A Experimental

Intranasal ketamine low dose

B Experimental

intranasal ketamine medium dose

C Experimental

intranasal ketamine high dose

D Placebo Comparator

placebo

Criteria 

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
No Results Posted