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

Javelin Pharmaceuticals40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain, Postoperative

Interventions

intranasal ketamineDRUG

low dose

intranasal ketamineDRUG

medium dose

intranasal ketamineDRUG

high dose

placebo

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

total pain relief over 0-3 hours following dosing

Time frame: 3 hours

Secondary Outcomes

other pain assessments

Time frame: 3 hours

Data from ClinicalTrials.gov

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