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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00488787

Enrollment

Registered

2007-06-20

Start date

2001-03-31

Completion date

2001-04-30

Last updated

2008-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

dental, surgery, analgesia, 2-4 impacted third molars

Brief 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.

Interventions

DRUGintranasal ketamine

low dose

DRUGplacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
total pain relief over 0-3 hours following dosing	3 hours

Secondary

Measure	Time frame
other pain assessments	3 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026