Nasal ObstructionNCT02294162
Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?
A study testing Ketamine i.v in people with Nasal Obstruction, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
Pain is an unpleasant sensory experience associated with actual or potential tissue damage. Acute pain management is an important aspect of perioperative anesthetic care. Moreover, it is the most important factor related to patient discomfort after surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Nasal Obstruction
- What is being tested?
- Ketamine i.v
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2015to 1 Oct 2017
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing submucosal resection of nasal septum with or without turbinectomy.
- Over 18 years of age.
- ASA (anesthsiology Severity Score) score of 1-2.
- Signed informed consent by patient or caregiver.
Who cannot join
- Allergy to Ketamine
- Unable/ unwilling to comply with the protocol requirements
- Pregnancy or breast feeding
- Chronic use of analgetics
- History of alcohol and/or drug abuse
- Previous nasal surgry
Trial locations and contacts
1 site in 1 country.
About this study
Pain is an unpleasant sensory experience associated with actual or potential tissue damage. Acute pain management is an important aspect of perioperative anesthetic care. Moreover, it is the most important factor related to patient discomfort after surgery. Adequate pain management, ideally resulting in the complete absence of postoperative pain, not only provides comfort to patients, but may also contribute to improved healing and a reduction in the incidence of postoperative complications. Inadequate postoperative analgesia has been shown to contribute to adverse outcomes, including, but not limited to, immunosuppression, hyperglycemia, poor rehabilitation, and progression to chronic pain.
Read the detailed description
Patients who are scheduled for submucosal resection of nasal septum with or without turbinectomy will be recruited for the study The patients will be will be assigned to either the treatment group who will be administered ketamine prior to the operation or the control group who will receive a normal saline injection, both in identicle syringes.
All patients will be operated on by the same surgoens and by the same method of dissection and hemostasis (2-5 2 ml lidocadrain carpules, monopolar suction-cautery set on 25).
Patients folow-up will be reported in their medical charts. The post operative analgetic effect will be assessed by the amount of analgesia required in the post-operative period and by regular pain measurements using VAS (Visual Analogue Scale) - at 0.5 hours post operation in the recovery room, 8 hours post operation and the morning of first post operative day in the otolaryngology - head and neck department
- Conditions
- Nasal Obstruction
- Being tested
- Ketamine i.v
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine i.vDrug
| Study group | Role | What they receive |
|---|---|---|
| 0.5 mg/kg body weight Ketamin | Experimental | Patients allocated to this arm will receive an iv dose of 0.5 mg/kg body weight ketamine. Receives: Drug: Ketamine i.v |
| 5 ml normal saline as placebo | Placebo comparator | Patients allocated to this arm will receive an iv dose of 5ml saline as placebo. Receives: Drug: Ketamine i.v |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain: reduction in severity based on VAS score.
The post operative analgetic effect will be assessed by the amount of analgesia required in the post-operative period and by regular pain measurements using VAS (Visual Analogue Scale) - at 0.5 hours post operation in the recovery room, 8 hours post operation and the morning of first post operative day
Measured: the morning of first post operative day
consumption of postoperative pain medication type, dosage and reduction in the demand postoperatively.
The data will be collected from the medical file
Measured: the morning of first post operative day
Secondary outcomes (2)
Readmission for any reason.
Measured: one week
Duration of hospital stay.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study start1 Apr 2015
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Why it stopped: Terminated by IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal ObstructionStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ronen Ohad, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294162
- Sponsor's protocol ID
- 0104-14
- Status last verified
- Oct 2018
- First submitted
- 14 Nov 2014
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?
- ClinicalTrials.gov ID
- NCT02294162
- Acronym / sponsor ID
- 0104-14
- Conditions
- Nasal Obstruction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated by IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 19 Nov 2014 (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.
Pain is an unpleasant sensory experience associated with actual or potential tissue damage. Acute pain management is an important aspect of perioperative anesthetic care. Moreover, it is the most important factor related to patient discomfort after surgery. Adequate pain management, ideally resulting in the complete absence of postoperative pain, not only provides comfort to patients, but may also contribute to improved healing and a reduction in the incidence of postoperative complications. Inadequate postoperative analgesia has been shown to contribute to adverse outcomes, including, but not limited to, immunosuppression, hyperglycemia, poor rehabilitation, and progression to chronic pain.
Detailed description
Patients who are scheduled for submucosal resection of nasal septum with or without turbinectomy will be recruited for the study The patients will be will be assigned to either the treatment group who will be administered ketamine prior to the operation or the control group who will receive a normal saline injection, both in identicle syringes.
All patients will be operated on by the same surgoens and by the same method of dissection and hemostasis (2-5 2 ml lidocadrain carpules, monopolar suction-cautery set on 25).
Patients folow-up will be reported in their medical charts. The post operative analgetic effect will be assessed by the amount of analgesia required in the post-operative period and by regular pain measurements using VAS (Visual Analogue Scale) - at 0.5 hours post operation in the recovery room, 8 hours post operation and the morning of first post operative day in the otolaryngology - head and neck department
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5 mg/kg body weight Ketamin | Experimental | Drug: Ketamine i.vPatients allocated to this arm will receive an iv dose of 0.5 mg/kg body weight ketamine. |
| 5 ml normal saline as placebo | Placebo comparator | Drug: Ketamine i.vPatients allocated to this arm will receive an iv dose of 5ml saline as placebo. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing submucosal resection of nasal septum with or without turbinectomy.
- Over 18 years of age.
- ASA (anesthsiology Severity Score) score of 1-2.
- Signed informed consent by patient or caregiver.
Key exclusion criteria (6 listed)
- Allergy to Ketamine
- Unable/ unwilling to comply with the protocol requirements
- Pregnancy or breast feeding
- Chronic use of analgetics
- History of alcohol and/or drug abuse
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 |
|---|---|---|
| Ketamine i.v | Drug | 0.5 mg/kg body weight Ketamin, 5 ml normal saline as placebo |
Primary outcome
Pain: reduction in severity based on VAS score.
Time frame: the morning of first post operative day
The post operative analgetic effect will be assessed by the amount of analgesia required in the post-operative period and by regular pain measurements using VAS (Visual Analogue Scale) - at 0.5 hours post operation in the recovery room, 8 hours post operation and the morning of first post operative day
consumption of postoperative pain medication type, dosage and reduction in the demand postoperatively.
Time frame: the morning of first post operative day
The data will be collected from the medical file
2 secondary outcomes
Readmission for any reason.
Time frame: one week
Duration of hospital stay.
Time frame: one week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine i.v in people with Nasal Obstruction, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 3 Oct 2018. 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 Israel. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain: reduction in severity based on VAS score. (time frame: the morning of first post operative day). The study lists 2 primary outcomes in all. 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 3 Oct 2018.