NCT00488787

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2001

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2007

Completed
Last Updated

February 7, 2008

Status Verified

February 1, 2008

Enrollment Period

1 month

First QC Date

June 19, 2007

Last Update Submit

February 5, 2008

Conditions

Pain, Postoperative

Keywords

dentalsurgeryanalgesia2-4 impacted third molars

Outcome Measures

Primary Outcomes (1)

  • total pain relief over 0-3 hours following dosing

    3 hours

Secondary Outcomes (1)

  • other pain assessments

    3 hours

Study Arms (4)

A

EXPERIMENTAL

Intranasal ketamine low dose

Drug: intranasal ketamine

B

EXPERIMENTAL

intranasal ketamine medium dose

Drug: intranasal ketamine

C

EXPERIMENTAL

intranasal ketamine high dose

Drug: intranasal ketamine

D

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

intranasal ketamineDRUG

low dose

A
placeboDRUG

placebo

D

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Less than 16 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Kyle Christensen, DDS

    Jean Brown Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 19, 2007

First Posted

June 20, 2007

Study Start

March 1, 2001

Primary Completion

April 1, 2001

Study Completion

April 1, 2001

Last Updated

February 7, 2008

Record last verified: 2008-02