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

NCT ID: NCT00488787

Last Updated: 2008-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2001-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Intranasal ketamine low dose

Group Type EXPERIMENTAL

intranasal ketamine

Intervention Type DRUG

low dose

B

intranasal ketamine medium dose

Group Type EXPERIMENTAL

intranasal ketamine

Intervention Type DRUG

medium dose

C

intranasal ketamine high dose

Group Type EXPERIMENTAL

intranasal ketamine

Intervention Type DRUG

high dose

D

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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intranasal ketamine

low dose

Intervention Type DRUG

intranasal ketamine

medium dose

Intervention Type DRUG

intranasal ketamine

high dose

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy patients at least 16 years of age requiring two or more third molar extractions

Exclusion Criteria

* Less than 16 years old
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Javelin Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Javelin Pharmaceuticals

Principal Investigators

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Kyle Christensen, DDS

Role: PRINCIPAL_INVESTIGATOR

Jean Brown Associates

Other Identifiers

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KET-003

Identifier Type: -

Identifier Source: org_study_id

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