Mouth and Tooth DiseasesPhase 4NCT00232492
Ketamine on Acute Pain in Females and Males
A Phase 4 study testing Ketamine 0,1 mg/kg males, Ketamine 0,3 mg/kg males and Ketamine 0,5 mg/kg males in people with Mouth and Tooth Diseases and Tooth, Impacted, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
The purpose of the study is to determine whether equal subanesthetic doses of racemic ketamine is equally effective on females and males after surgical removal of third molars Read more about this study
- Who is it for?
- Ages 20 to 30 years
- Conditions the study is for
- Mouth and Tooth Diseases, Tooth, Impacted
- What is being tested?
- Ketamine 0,1 mg/kg males, Ketamine 0,3 mg/kg males and Ketamine 0,5 mg/kg males
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2005to Nov 2006
- Phase
- Phase 4
- 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 20 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Indication for removal of third molar
- Between 20 and 30 years of age
- ASA Class 1
Who cannot join
- Psychiatric family (father/mother) or own anamnestic history
- Hypersensitivity towards NSAIDS or other rescue analgesics
- Verified or suspected pregnancy
- Lactating females
- Surgery lasting over 60 min
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Oral and Maxillofacial Surgery, Ullevaal University Hospital
Oslo, NO-0407
About this study
Official title: Effect of Racemic Ketamine on Pain in Females and Males After Surgical Removal of Third Molars
The purpose of the study is to determine whether equal subanesthetic doses of racemic ketamine is equally effective on females and males after surgical removal of third molars
Read the detailed description
Ketamine is assumed to be a NMDA receptor antagonist which provides analgesia from acute postoperative pain(and other types of pain) subanesthetic doses. Gender differences in ketamine analgesia are not known. This placebo-controlled,randomised, parallel group study investigates the analgesic dose-response effect of ketamine in subanesthetic doses in female and male patients following surgical removal of third molars.
Comparisons: Placebo and ketamine in females and males.
- Conditions
- Mouth and Tooth Diseases, Tooth, Impacted
- Being tested
- Placebo males, Ketamine 0,1 mg/kg males, Ketamine 0,3 mg/kg males, Ketamine 0,5 mg/kg males, Placebo females
- Keywords
- Wisdom, Tooth, Teeth, Third, Molar
- Medical subject headings
- Stomatognathic Diseases, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo malesDrug
Also called saline physiological 5 ml
Intravenous saline bolus (Placebo-control) males
Ketamine 0,1 mg/kg malesDrug
Also called Ketalar ATC-nr.: N01A X03
0,1 mg/kg ketamine iv bolus males
Ketamine 0,3 mg/kg malesDrug
Also called Ketalar ATC-nr.: N01A X03
0,3 mg/kg ketamine iv bolus males
Ketamine 0,5 mg/kg malesDrug
Also called Ketalar ATC-nr.: N01A X03
0,5 mg/kg ketamine iv bolus males
Placebo femalesDrug
Also called Saline physiological 5 ml
Intravenous saline bolus (Placebo-control) females
Ketamine 0,1 mg/kg femalesDrug
Also called Ketalar ATC-nr.: N01A X03
0,1 mg/kg iv bolus ketamine females
Ketamine 0,3 mg/kg femalesDrug
Also called Ketalar ATC-nr.: N01A X03
0,3 mg/kg iv bolus ketamine females
Ketamine 0,5 mg/kg femalesDrug
Also called Ketalar ATC-nr.: N01A X03
0,5 mg/kg iv bolus ketamine females
| Study group | Role | What they receive |
|---|---|---|
| Placebo males | Placebo comparator | Saline physiological placebo males Receives: Drug: Placebo males |
| Ketamine 0,1 mg/kg males | Active comparator | 0,1 mg/kg ketamine males Receives: Drug: Ketamine 0,1 mg/kg males |
| Ketamine 0,3 mg/kg males | Active comparator | 0,3 mg/kg ketamine males Receives: Drug: Ketamine 0,3 mg/kg males |
| Ketamine 0,5 mg/kg males | Active comparator | 0,5 mg/kg ketamine males Receives: Drug: Ketamine 0,5 mg/kg males |
| Placebo females | Placebo comparator | Saline physiological as placebo females Receives: Drug: Placebo females |
| Ketamine 0.1 mg/kg females | Active comparator | 0,1 mg/kg ketamine females Receives: Drug: Ketamine 0,1 mg/kg females |
| Ketamine 0,3 mg/kg females | Active comparator | 0,3 mg/kg ketamine females Receives: Drug: Ketamine 0,3 mg/kg females |
| Ketamine 0,5 mg/kg females | Active comparator | 0,5 mg/kg ketamine females Receives: Drug: Ketamine 0,5 mg/kg females |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum pain NRS
Measured: 60 min
Secondary outcomes (1)
Several subjective variables assessing psychotomimetic effects
Measured: 0, 15, 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startJan 2005
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mouth and Tooth DiseasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Investigators
- Lasse A Skoglund, DDS, PhD, Study chair, Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, NorwayOlav Hustveit, MD, Principal investigator, Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232492
- Sponsor's protocol ID
- DOK-015
- Status last verified
- Apr 2008
- First submitted
- 30 Sep 2005
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Oye I, Mathisen LC. The effect of CPP in neurogenic pain: inhibition of spinal or cortical NMDA receptors? Pain. 1993 Jun;53(3):358. doi: 10.1016/0304-3959(93)90234-G. No abstract available.
PubMed 8351166Øye I, Hustveit O, Maurset A, Ratti Moberg E, Paulsen O, Skoglund LA. The chiral forms of ketamine as probes for NMDA receptor functions in humans. In: NMDA receptor related agents: Biochemistry, pharmacology and behaviour. Kameyama T, Domino E (eds). NPP Books, Ann Arbor, 1991.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Racemic Ketamine on Pain in Females and Males After Surgical Removal of Third Molars
- ClinicalTrials.gov ID
- NCT00232492
- Acronym / sponsor ID
- DOK-015
- Conditions
- Mouth and Tooth Diseases, Tooth, Impacted
- Keywords
- Wisdom, Tooth, Teeth, Third, Molar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Jan 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 4 Oct 2005 (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.
The purpose of the study is to determine whether equal subanesthetic doses of racemic ketamine is equally effective on females and males after surgical removal of third molars
Detailed description
Ketamine is assumed to be a NMDA receptor antagonist which provides analgesia from acute postoperative pain(and other types of pain) subanesthetic doses. Gender differences in ketamine analgesia are not known. This placebo-controlled,randomised, parallel group study investigates the analgesic dose-response effect of ketamine in subanesthetic doses in female and male patients following surgical removal of third molars.
Comparisons: Placebo and ketamine in females and males.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Placebo males | Placebo comparator | Drug: Placebo malesSaline physiological placebo males |
| Ketamine 0,1 mg/kg males | Active comparator | Drug: Ketamine 0,1 mg/kg males0,1 mg/kg ketamine males |
| Ketamine 0,3 mg/kg males | Active comparator | Drug: Ketamine 0,3 mg/kg males0,3 mg/kg ketamine males |
| Ketamine 0,5 mg/kg males | Active comparator | Drug: Ketamine 0,5 mg/kg males0,5 mg/kg ketamine males |
| Placebo females | Placebo comparator | Drug: Placebo femalesSaline physiological as placebo females |
| Ketamine 0.1 mg/kg females | Active comparator | Drug: Ketamine 0,1 mg/kg females0,1 mg/kg ketamine females |
| Ketamine 0,3 mg/kg females | Active comparator | Drug: Ketamine 0,3 mg/kg females0,3 mg/kg ketamine females |
| Ketamine 0,5 mg/kg females | Active comparator | Drug: Ketamine 0,5 mg/kg females0,5 mg/kg ketamine females |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Indication for removal of third molar
- Between 20 and 30 years of age
- ASA Class 1
Key exclusion criteria (5 listed)
- Psychiatric family (father/mother) or own anamnestic history
- Hypersensitivity towards NSAIDS or other rescue analgesics
- Verified or suspected pregnancy
- Lactating females
- Surgery lasting over 60 min
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 |
|---|---|---|
| Placebo malesAlso: saline physiological 5 mlIntravenous saline bolus (Placebo-control) males | Drug | Placebo males |
| Ketamine 0,1 mg/kg malesAlso: Ketalar ATC-nr.: N01A X030,1 mg/kg ketamine iv bolus males | Drug | Ketamine 0,1 mg/kg males |
| Ketamine 0,3 mg/kg malesAlso: Ketalar ATC-nr.: N01A X030,3 mg/kg ketamine iv bolus males | Drug | Ketamine 0,3 mg/kg males |
| Ketamine 0,5 mg/kg malesAlso: Ketalar ATC-nr.: N01A X030,5 mg/kg ketamine iv bolus males | Drug | Ketamine 0,5 mg/kg males |
| Placebo femalesAlso: Saline physiological 5 mlIntravenous saline bolus (Placebo-control) females | Drug | Placebo females |
| Ketamine 0,1 mg/kg femalesAlso: Ketalar ATC-nr.: N01A X030,1 mg/kg iv bolus ketamine females | Drug | Ketamine 0.1 mg/kg females |
| Ketamine 0,3 mg/kg femalesAlso: Ketalar ATC-nr.: N01A X030,3 mg/kg iv bolus ketamine females | Drug | Ketamine 0,3 mg/kg females |
| Ketamine 0,5 mg/kg femalesAlso: Ketalar ATC-nr.: N01A X030,5 mg/kg iv bolus ketamine females | Drug | Ketamine 0,5 mg/kg females |
Primary outcome
Sum pain NRS
Time frame: 60 min
1 secondary outcome
Several subjective variables assessing psychotomimetic effects
Time frame: 0, 15, 60
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 6 Jul 2011.
- Background: PubMed 8351166Oye I, Mathisen LC. The effect of CPP in neurogenic pain: inhibition of spinal or cortical NMDA receptors? Pain. 1993 Jun;53(3):358. doi: 10.1016/0304-3959(93)90234-G. No abstract available.
- BackgroundØye I, Hustveit O, Maurset A, Ratti Moberg E, Paulsen O, Skoglund LA. The chiral forms of ketamine as probes for NMDA receptor functions in humans. In: NMDA receptor related agents: Biochemistry, pharmacology and behaviour. Kameyama T, Domino E (eds). NPP Books, Ann Arbor, 1991.
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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.
Lasse A Skoglund, DDS, PhD study chair
Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway
Olav Hustveit, MD principal investigator
Section of Dental Pharmacology and Pharmacotherapy, Faculty of Dentistry, POB 1119 Blindern, University of Oslo, N-0317 Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine 0,1 mg/kg males, Ketamine 0,3 mg/kg males and Ketamine 0,5 mg/kg males in people with Mouth and Tooth Diseases and Tooth, Impacted, run by Ullevaal University Hospital at 1 site in Norway.
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 3 inclusion and 5 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 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Sum pain NRS (time frame: 60 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00232492, which also lists 2 linked publications.
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 6 Jul 2011.