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

Pain, Postoperative Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488787
• Other study ID #: KET-003
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2007
• Last updated: February 5, 2008
• Start date: March 2001
• Est. completion date: April 2001

Study information

• Verified date: February 2008
• Source: Javelin Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2001
• Est. primary completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• intranasal ketamine
low dose
• intranasal ketamine
medium dose
• intranasal ketamine
high dose
• placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Javelin Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total pain relief over 0-3 hours following dosing		3 hours	No
Secondary	other pain assessments		3 hours	No