Pre-emptive Analgesia in Different Psycho-emotional Status PatientsNCT04202224
Pre-emptive Analgesia Effect in Different Psycho-emotional Status Patients During Lower Third Molar Surgical Extractions
A study testing Ibuprofen 400 mg and Acetaminophen 500 mg, Glucose and No drug in people with Pre-emptive Analgesia in Different Psycho-emotional Status Patients, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
To increase the effectiveness of pain control, it is recommended to use drugs before the pain onset, therefore the pre-emptive analgesia method is considered as a method, which allows decreasing the post-operative pain to minimum. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre-emptive Analgesia in Different Psycho-emotional Status Patients
- What is being tested?
- Ibuprofen 400 mg and Acetaminophen 500 mg, Glucose and No drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Oct 2018to 30 May 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients;
- Indications for mandibular third molar removal.
Who cannot join
- Presence of NSAID usage;
- Acute inflammation in operating site;
- General diseases that might negatively influence the outcomes of operation, such as epilepsy, unstable neurological condition;
- Anticoagulant usage;
- Diabetes mellitus;
- Cardiovascular diseases.
Trial locations and contacts
1 site in 1 country.
About this study
To increase the effectiveness of pain control, it is recommended to use drugs before the pain onset, therefore the pre-emptive analgesia method is considered as a method, which allows decreasing the post-operative pain to minimum. Previous studies evaluated effectiveness of pre-emptive analgesia but no relation to psycho-emotional status was addressed. Our authors believe that the effect of pre-emptive analgesia may vary based on different psycho-emotional status.
45 volunteers who needed extraction of lower third molars were examined and enrolled in the study (study group - 15; placebo - 15; control - 15 volunteers). Ibuprofen 400mg together with 500mg paracetamol was used for pre-emptive analgesia. Difficulty of the operation, heart rate measurements and operation protocol were documented. Surgeon filled his questionnaire after the procedure. Patients on consultation, operation day and 10 days postop. filled a questionnaire which consisted of general, special and pain evaluation sections. Less favorable psycho-emotional status correlated with more severe pain 6h after operation. This relation was mostly expressed in the control group. Psycho-emotional status of placebo patients was accounted for bigger analgesic consumption frequency. Postoperative pain in study group was minimal compared to other groups. Pre-emptive analgesia enhances patient's psycho-emotional status and sustains postoperative pain control during lower third molar surgical extractions.
- Being tested
- Ibuprofen 400 mg and Acetaminophen 500 mg, Glucose, No drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 400 mg and Acetaminophen 500 mgDrug
Analgesia.
GlucoseDrug
Placebo.
No drugOther
Standard surgical procedure without any preoperative medication.
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Receives pre-emptive analgesia 30min. prior to third molar extraction. NSAID: Ibuprofen 400mg and Acetaminophen 500mg/ Receives: Drug: Ibuprofen 400 mg and Acetaminophen 500 mg |
| Placebo | Placebo comparator | Receives glucose tablets as pre-emptive analgesia 30min. prior to third molar extraction. Receives: Drug: Glucose |
| Control | Active comparator | Receives no medication prior to third molar extraction. Receives: Other: No drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-emptive analgesia is effective in a negative psycho-emotional status patients
Pre-emptive analgesia prior to third molard extraction is effective in different psycho-emotional status patients
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 Oct 2018
- Primary completion1 Feb 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-emptive Analgesia in Different Psycho-emotional Status PatientsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomas Puidokas, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202224
- Sponsor's protocol ID
- 5995
- Status last verified
- Dec 2019
- First submitted
- 15 Dec 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-emptive Analgesia Effect in Different Psycho-emotional Status Patients During Lower Third Molar Surgical Extractions
- ClinicalTrials.gov ID
- NCT04202224
- Acronym / sponsor ID
- 5995
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 17 Dec 2019 (actual)
- 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.
To increase the effectiveness of pain control, it is recommended to use drugs before the pain onset, therefore the pre-emptive analgesia method is considered as a method, which allows decreasing the post-operative pain to minimum. Previous studies evaluated effectiveness of pre-emptive analgesia but no relation to psycho-emotional status was addressed. Our authors believe that the effect of pre-emptive analgesia may vary based on different psycho-emotional status.
45 volunteers who needed extraction of lower third molars were examined and enrolled in the study (study group - 15; placebo - 15; control - 15 volunteers). Ibuprofen 400mg together with 500mg paracetamol was used for pre-emptive analgesia. Difficulty of the operation, heart rate measurements and operation protocol were documented. Surgeon filled his questionnaire after the procedure. Patients on consultation, operation day and 10 days postop. filled a questionnaire which consisted of general, special and pain evaluation sections. Less favorable psycho-emotional status correlated with more severe pain 6h after operation. This relation was mostly expressed in the control group. Psycho-emotional status of placebo patients was accounted for bigger analgesic consumption frequency. Postoperative pain in study group was minimal compared to other groups. Pre-emptive analgesia enhances patient's psycho-emotional status and sustains postoperative pain control during lower third molar surgical extractions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Drug: Ibuprofen 400 mg and Acetaminophen 500 mgReceives pre-emptive analgesia 30min. prior to third molar extraction. NSAID: Ibuprofen 400mg and Acetaminophen 500mg/ |
| Placebo | Placebo comparator | Drug: GlucoseReceives glucose tablets as pre-emptive analgesia 30min. prior to third molar extraction. |
| Control | Active comparator | Other: No drugReceives no medication prior to third molar extraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients;
- Indications for mandibular third molar removal.
Key exclusion criteria (6 listed)
- Presence of NSAID usage;
- Acute inflammation in operating site;
- General diseases that might negatively influence the outcomes of operation, such as epilepsy, unstable neurological condition;
- Anticoagulant usage;
- Diabetes mellitus;
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 |
|---|---|---|
| Ibuprofen 400 mg and Acetaminophen 500 mgAnalgesia. | Drug | Study |
| GlucosePlacebo. | Drug | Placebo |
| No drugStandard surgical procedure without any preoperative medication. | Other | Control |
Primary outcome
Pre-emptive analgesia is effective in a negative psycho-emotional status patients
Time frame: 4 months
Pre-emptive analgesia prior to third molard extraction is effective in different psycho-emotional status patients
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 17 Dec 2019.
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 Ibuprofen 400 mg and Acetaminophen 500 mg, Glucose and No drug in people with Pre-emptive Analgesia in Different Psycho-emotional Status Patients, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 2 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: finished, as of the sponsor's last update on 17 Dec 2019. 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 Lithuania. 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 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?
Pre-emptive analgesia is effective in a negative psycho-emotional status patients (time frame: 4 months). 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 17 Dec 2019.