Adverse Anesthesia OutcomeNCT02884921
Preemptive Analgesia Using Intravenous Paracetamol
A study testing Paracetamol in people with Adverse Anesthesia Outcome, run by Bnai Zion Medical Center.
Trial summary
Dental treatment for children should be done in a calm atmosphere and without pain. Oral Propacetamol has been shown to be effective in a variety of postsurgical pain models. There are no studies on paracetamol preemptive analgesia effect on the pediatric population in the dental setting which compare analgesic effect… Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Adverse Anesthesia Outcome
- What is being tested?
- Paracetamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Aug 2016
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children who require a wide treatment of caries
- Children of high score of anxious or who is stressfully
Who cannot join
- Contraindication for paracetamol
- Renal or hepatic insufficiency
- Patient have history of allergy for paracetamol
- Anemia of Hgb less than 10 gr/DL
About this study
Official title: Preemptive Analgesia Using Intravenous Paracetamol in Dental Sitting
Dental treatment for children should be done in a calm atmosphere and without pain. Oral Propacetamol has been shown to be effective in a variety of postsurgical pain models.
There are no studies on paracetamol preemptive analgesia effect on the pediatric population in the dental setting which compare analgesic effect when administered before Vs after the dental treatment.
The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the prevention of postoperative pain in children undergoing dental treatment.
Read the detailed description
Dental treatment for children should be done in a calm atmosphere and without pain in purpose to achieve a positive feelings and response towards dental treatment.Postoperative pain is the main issue which may cause a negative attitude of the child to dental treatment in future appointment. One of the affective options to deal with this pain is to give analgesic drug before the initiative of treatment which should continue its effect during and may also after treatment which is known as "preemptive analgesia. Oral Propacetamol has been shown to be effective in a variety of postsurgical pain models. In double blind clinical trials single or multiple dose of intravenous paracetamol, generally provided significantly better analgesic effect than placebo treatment in adults' patients who had undergone dental, orthopedic or gynecological surgery. There is considerable evidence that the analgesic effect of paracetamol is central and is due to activation of descending serotonergic pathways, but its primary site of action may still be inhibition of prostaglandin synthesis by its selective inhibition of Cox-2 isoenzyme.
At the best of the investigators knowledge, there are no studies on paracetamol preemptive analgesia effect on the pediatric population in the dental setting which compare analgesic effect when administered before Vs after the dental treatment.
The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the prevention or modification of postoperative pain in children undergoing dental treatment.
The primary outcome of this study is to investigate the post dental treatment analgesic effect of intravenous paracetamol in children when administered before compared to after dental treatment.
- Conditions
- Adverse Anesthesia Outcome
- Being tested
- Paracetamol, Placebo
- Keywords
- Postoperative pain, Dental treatment, Paracetamol
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Paracetamol
ParacetamolDrug
Paracetamol
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Preemptive Paracetamol | Active comparator | Preemptive Paracetamol Receives: Drug: Paracetamol |
| Post surgery Paracetamol | Active comparator | Post surgery Paracetamol Receives: Drug: Paracetamol |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measure in numerical scale
Post operative Pain measure in numerical scale from 1 to 10
Measured: 1-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startApr 2015
- Primary completionApr 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Anesthesia OutcomeStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, LUIS.GAITINI, Bnai Zion Medical Center
- Investigators
- mira koch, Study chair, Ethicla Committee Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884921
- Sponsor's protocol ID
- BnaiZionMC-16-LG-008
- Status last verified
- Aug 2016
- First submitted
- 21 Aug 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Analgesia Using Intravenous Paracetamol in Dental Sitting
- ClinicalTrials.gov ID
- NCT02884921
- Acronym / sponsor ID
- BnaiZionMC-16-LG-008
- Conditions
- Adverse Anesthesia Outcome
- Keywords
- Postoperative pain, Dental treatment, Paracetamol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Apr 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 31 Aug 2016 (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.
Dental treatment for children should be done in a calm atmosphere and without pain. Oral Propacetamol has been shown to be effective in a variety of postsurgical pain models.
There are no studies on paracetamol preemptive analgesia effect on the pediatric population in the dental setting which compare analgesic effect when administered before Vs after the dental treatment.
The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the prevention of postoperative pain in children undergoing dental treatment.
Detailed description
Dental treatment for children should be done in a calm atmosphere and without pain in purpose to achieve a positive feelings and response towards dental treatment.Postoperative pain is the main issue which may cause a negative attitude of the child to dental treatment in future appointment. One of the affective options to deal with this pain is to give analgesic drug before the initiative of treatment which should continue its effect during and may also after treatment which is known as "preemptive analgesia. Oral Propacetamol has been shown to be effective in a variety of postsurgical pain models. In double blind clinical trials single or multiple dose of intravenous paracetamol, generally provided significantly better analgesic effect than placebo treatment in adults' patients who had undergone dental, orthopedic or gynecological surgery. There is considerable evidence that the analgesic effect of paracetamol is central and is due to activation of descending serotonergic pathways, but its primary site of action may still be inhibition of prostaglandin synthesis by its selective inhibition of Cox-2 isoenzyme.
At the best of the investigators knowledge, there are no studies on paracetamol preemptive analgesia effect on the pediatric population in the dental setting which compare analgesic effect when administered before Vs after the dental treatment.
The investigators hypothesis is that preoperative intravenous paracetamol are helpful in the prevention or modification of postoperative pain in children undergoing dental treatment.
The primary outcome of this study is to investigate the post dental treatment analgesic effect of intravenous paracetamol in children when administered before compared to after dental treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preemptive Paracetamol | Active comparator | Drug: ParacetamolPreemptive Paracetamol |
| Post surgery Paracetamol | Active comparator | Drug: ParacetamolPost surgery Paracetamol |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All children who require a wide treatment of caries
- Children of high score of anxious or who is stressfully
Key exclusion criteria (4 listed)
- Contraindication for paracetamol
- Renal or hepatic insufficiency
- Patient have history of allergy for paracetamol
- Anemia of Hgb less than 10 gr/DL
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 |
|---|---|---|
| ParacetamolParacetamol | Drug | Preemptive Paracetamol |
| ParacetamolParacetamol | Drug | Post surgery Paracetamol |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Pain measure in numerical scale
Time frame: 1-24 hours
Post operative Pain measure in numerical scale from 1 to 10
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 31 Aug 2016.
- Individual participant dataSharing planned: Yes
Related trials for Adverse Anesthesia Outcome
RecruitingPhase 4
Comparing the Safety and Effectiveness of Different Doses of Morphine Administered in Spinal Anethesia for Pain Relief After Hip Replacement Surgery
Analgesics, Opioid, Anesthesia, Spinal
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.
mira koch study chair
Ethicla Committee Bnai Zion Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol in people with Adverse Anesthesia Outcome, run by Bnai Zion Medical Center.
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 4 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 31 Aug 2016. 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.
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?
Pain measure in numerical scale (time frame: 1-24 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 31 Aug 2016.