Pain, PostoperativeEarly Phase 1NCT02393339
Pre-operative Analgesics for Postoperative Pain Relief After Dental Treatment
A Early Phase 1 study testing paracetamol in people with Pain, Postoperative and Analgesia, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The aim of the study is to compare the efficacy of the pre-operative administration of Paracetamol and placebo in reducing postoperative pain after routine dental treatment in children. This study will be a prospective, placebo-controlled, randomized, double-blind trial. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Analgesia
- What is being tested?
- paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Feb 2017to 31 Jan 2020
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy
- in need of dental treatment with local anesthesia
Who cannot join
- preoperative pain,
- patients taking analgesics within 5 h prior to the dental treatment
- allergic reaction or adverse effect to paracetamol
- not available (by phone) at least 2 hours after treatment
- patient refuse to drink the syrup
- dental treatment without local anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to compare the efficacy of the pre-operative administration of Paracetamol and placebo in reducing postoperative pain after routine dental treatment in children. This study will be a prospective, placebo-controlled, randomized, double-blind trial. Patients in need of dental treatment with local anesthesia will take part in the study.
Study group will receive syrup paracetamol 15 min before the dental treatment. Control group will receive placebo syrup, similar in color and viscosity, 15 min before dental treatment. the patient, the treating dentist, and the interviewer will be blind to the medication.
Main outcome measure: one of the main investigators will interview the patient at three time points: immediately at the end of the treatment, one hour after taking the pre-operative analgesic and by phone 2.5 hours after taking the pre-operative analgesic. The patient and his parents will be asked if the child is crying (yes/no), complaining about pain (yes/no), needed a different kind of analgesics after the treatment (yes/no). In addition, each child will describe his ⁄ her feelings regarding postoperative pain, using the Wong-Baker Facial Rating Pain Scale
Read the detailed description
This study will be a prospective, placebo-controlled, randomized, double-blind trial. Patients 5-12 years old, healthy, in need of dental treatment with local anesthesia of Lidocaine 2% with adrenalin 1:100,000 in the Hadassah School of Dental Medicine will take part in the study. The dental treatment will include one of the following procedures: restoration, pulpotomy, pulpectomy, stainless steel crown, extraction. Exclusion criteria: preoperative pain, patients taking analgesics within 5 h prior to the dental treatment, allergic reaction or adverse effect to paracetamol, not available (by phone) at least 2 hours after treatment, patient refuse to drink the syrup.
Study group will receive syrup paracetamol 15 min before the dental treatment. Control group will receive placebo syrup, similar in color and viscosity, 15 min before dental treatment. the patient, the treating dentist, and the interviewer will be blind to the medication.
Data collection: age, gender, type of treatment, type of LA (infiltration /block), time of taking the preoperative analgesic, type of preoperative analgesics ( 1 or 2), time at the end of the treatment and baseline apprehension. Baseline anxiety will be recorded prior to the procedure using Facial Image Scale.
Main outcome measure: one of the main investigators will interview the patient at three time points: immediately at the end of the treatment, one hour after taking the pre-operative analgesic and by phone 2.5 hours after taking the pre-operative analgesic. The patient and his parents will be asked if the child is crying (yes/no), complaining about pain (yes/no), needed a different kind of analgesics after the treatment (yes/no). In addition, each child will describe his ⁄ her feelings regarding postoperative pain, using the Wong-Baker Facial Rating Pain Scale The first two parts of the questionnaire (time 0, 1 h) will be answered in the clinic and the last part (time 2.5 h) by phone; the children will have the scale with the faces with them.
- Conditions
- Pain, Postoperative, Analgesia
- Being tested
- paracetamol, placebo
- 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.
paracetamolDrug
Also called acetaminophen
Pre-operative administration of Paracetamol syrup
placeboDrug
Pre-operative administration of placebo syrup
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | Study group will receive syrup paracetamol (15 mg/kg) 15 min before the dental treatment Receives: Drug: paracetamol |
| controll group | Placebo comparator | Control group will receive placebo syrup, designed to mimic paracetamol syrup, similar in color and viscosity, 15 min before dental treatment. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment
This scale measures the unpleasantness or effective dimension of a child's pain experience. The child is shown a set of six cartoon faces with varying facial expressions from smile\laughter to tears. Each face has a numerical value, from 0 (smiling face) to 5 (tears). The child selects the facial expression that best represents his \her experience of discomfort.
Measured: 2.5 hours after taking the pre-operative analgesic.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study start1 Feb 2017
- Primary completion1 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avia Fux, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393339
- Sponsor's protocol ID
- 0638-14-HMO-CTIL
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2015
- Last updated
- 3 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Analgesics for Postoperative Pain Relief After Dental Treatment
- ClinicalTrials.gov ID
- NCT02393339
- Acronym / sponsor ID
- 0638-14-HMO-CTIL
- Conditions
- Pain, Postoperative, Analgesia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Posted 3 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare the efficacy of the pre-operative administration of Paracetamol and placebo in reducing postoperative pain after routine dental treatment in children. This study will be a prospective, placebo-controlled, randomized, double-blind trial. Patients in need of dental treatment with local anesthesia will take part in the study.
Study group will receive syrup paracetamol 15 min before the dental treatment. Control group will receive placebo syrup, similar in color and viscosity, 15 min before dental treatment. the patient, the treating dentist, and the interviewer will be blind to the medication.
Main outcome measure: one of the main investigators will interview the patient at three time points: immediately at the end of the treatment, one hour after taking the pre-operative analgesic and by phone 2.5 hours after taking the pre-operative analgesic. The patient and his parents will be asked if the child is crying (yes/no), complaining about pain (yes/no), needed a different kind of analgesics after the treatment (yes/no). In addition, each child will describe his ⁄ her feelings regarding postoperative pain, using the Wong-Baker Facial Rating Pain Scale
Detailed description
This study will be a prospective, placebo-controlled, randomized, double-blind trial. Patients 5-12 years old, healthy, in need of dental treatment with local anesthesia of Lidocaine 2% with adrenalin 1:100,000 in the Hadassah School of Dental Medicine will take part in the study. The dental treatment will include one of the following procedures: restoration, pulpotomy, pulpectomy, stainless steel crown, extraction. Exclusion criteria: preoperative pain, patients taking analgesics within 5 h prior to the dental treatment, allergic reaction or adverse effect to paracetamol, not available (by phone) at least 2 hours after treatment, patient refuse to drink the syrup.
Study group will receive syrup paracetamol 15 min before the dental treatment. Control group will receive placebo syrup, similar in color and viscosity, 15 min before dental treatment. the patient, the treating dentist, and the interviewer will be blind to the medication.
Data collection: age, gender, type of treatment, type of LA (infiltration /block), time of taking the preoperative analgesic, type of preoperative analgesics ( 1 or 2), time at the end of the treatment and baseline apprehension. Baseline anxiety will be recorded prior to the procedure using Facial Image Scale.
Main outcome measure: one of the main investigators will interview the patient at three time points: immediately at the end of the treatment, one hour after taking the pre-operative analgesic and by phone 2.5 hours after taking the pre-operative analgesic. The patient and his parents will be asked if the child is crying (yes/no), complaining about pain (yes/no), needed a different kind of analgesics after the treatment (yes/no). In addition, each child will describe his ⁄ her feelings regarding postoperative pain, using the Wong-Baker Facial Rating Pain Scale The first two parts of the questionnaire (time 0, 1 h) will be answered in the clinic and the last part (time 2.5 h) by phone; the children will have the scale with the faces with them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Drug: paracetamolStudy group will receive syrup paracetamol (15 mg/kg) 15 min before the dental treatment |
| controll group | Placebo comparator | Drug: placeboControl group will receive placebo syrup, designed to mimic paracetamol syrup, similar in color and viscosity, 15 min before dental treatment. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- healthy
- in need of dental treatment with local anesthesia
Key exclusion criteria (6 listed)
- preoperative pain,
- patients taking analgesics within 5 h prior to the dental treatment
- allergic reaction or adverse effect to paracetamol
- not available (by phone) at least 2 hours after treatment
- patient refuse to drink the syrup
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 |
|---|---|---|
| paracetamolAlso: acetaminophenPre-operative administration of Paracetamol syrup | Drug | study group |
| placeboPre-operative administration of placebo syrup | Drug | controll group |
Primary outcome
Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment
Time frame: 2.5 hours after taking the pre-operative analgesic.
This scale measures the unpleasantness or effective dimension of a child's pain experience. The child is shown a set of six cartoon faces with varying facial expressions from smile\laughter to tears. Each face has a numerical value, from 0 (smiling face) to 5 (tears). The child selects the facial expression that best represents his \her experience of discomfort.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Early Phase 1 study testing paracetamol in people with Pain, Postoperative and Analgesia, run by Hadassah Medical Organization 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 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 3 Mar 2021. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment (time frame: 2.5 hours after taking the pre-operative analgesic.). 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 Mar 2021.