Pain, PostoperativePhase 2NCT00488787
Safety and Efficacy of Intranasal Ketamine for the Treatment of Postoperative Dental Pain
A Phase 2 study testing intranasal ketamine in people with Pain, Postoperative, run by Javelin Pharmaceuticals.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- intranasal ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2001to Apr 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthy patients at least 16 years of age requiring two or more third molar extractions
Who cannot join
- Less than 16 years old
- Other exclusion criteria may apply
About this study
Official title: 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
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.
- Conditions
- Pain, Postoperative
- Being tested
- intranasal ketamine, placebo
- Keywords
- dental, surgery, analgesia, 2-4 impacted third molars
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal ketamineDrug
low dose
intranasal ketamineDrug
medium dose
intranasal ketamineDrug
high dose
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Intranasal ketamine low dose Receives: Drug: intranasal ketamine |
| B | Experimental | intranasal ketamine medium dose Receives: Drug: intranasal ketamine |
| C | Experimental | intranasal ketamine high dose Receives: Drug: intranasal ketamine |
| D | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
total pain relief over 0-3 hours following dosing
Measured: 3 hours
Secondary outcomes (1)
other pain assessments
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startMar 2001
- Primary completionApr 2001
- Study completionApr 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javelin Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kyle Christensen, DDS, Principal investigator, Jean Brown Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488787
- Sponsor's protocol ID
- KET-003
- Status last verified
- Feb 2008
- First submitted
- 19 Jun 2007
- Last updated
- 7 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00488787
- Acronym / sponsor ID
- KET-003
- Conditions
- Pain, Postoperative
- Keywords
- dental, surgery, analgesia, 2-4 impacted third molars
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Javelin PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2001
- Primary completion
- Apr 2001 (actual)
- Study completion
- Apr 2001 (actual)
- First posted
- 20 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: intranasal ketamineIntranasal ketamine low dose |
| B | Experimental | Drug: intranasal ketamineintranasal ketamine medium dose |
| C | Experimental | Drug: intranasal ketamineintranasal ketamine high dose |
| D | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy patients at least 16 years of age requiring two or more third molar extractions
Key exclusion criteria (2 listed)
- Less than 16 years old
- Other exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intranasal ketaminelow dose | Drug | A |
| intranasal ketaminemedium dose | Drug | B |
| intranasal ketaminehigh dose | Drug | C |
| placeboplacebo | Drug | D |
Primary outcome
total pain relief over 0-3 hours following dosing
Time frame: 3 hours
1 secondary outcome
other pain assessments
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Christensen, DDS principal investigator
Jean Brown Associates
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intranasal ketamine in people with Pain, Postoperative, run by Javelin Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total pain relief over 0-3 hours following dosing (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2008; AzTrials last refreshed its copy on 8 Nov 2026.