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

Javelin Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Pain, Postoperative

Treatments: Drug: placebo; Drug: intranasal ketamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00488787

KET-003

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 4 patient groups, including a placebo group

A

Experimental group

Description:

Intranasal ketamine low dose

Treatment:

Drug: intranasal ketamine

Drug: intranasal ketamine

Drug: intranasal ketamine

B

Experimental group

Description:

intranasal ketamine medium dose

Treatment:

Drug: intranasal ketamine

Drug: intranasal ketamine

Drug: intranasal ketamine

C

Experimental group

Description:

intranasal ketamine high dose

Treatment:

Drug: intranasal ketamine

Drug: intranasal ketamine

Drug: intranasal ketamine

D

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo