To Control Pain After Third Molar SurgeryPhase 4NCT03049878
Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery
A Phase 4 study testing Paracetamol Codeine in people with To Control Pain After Third Molar Surgery, run by University of Roma La Sapienza.
Trial summary
Objectives: The aim of this study was to determine the effectiveness of preoperative administration of single-dose of paracetamol-codeine, in the relieving of acute post-operative pain after the surgical removal of an impacted mandibular third molar. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- To Control Pain After Third Molar Surgery
- What is being tested?
- Paracetamol Codeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 21 Feb 2013to 10 Sep 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- absence of systemic pathologies (ASA class I);
- non-smoker;
- not pregnant or lactating;
- good oral hygiene;
- no drug consumption for 10 days before the operation;
- bilateral impacted mandibular third molars with comparable position, depth and inclination;
Show all 9Show fewer
- presence of the first and second molars;
- absence of painful symptoms and associated inflammatory or osteolytic pathologies in a radiographic examination;
- extraction difficulty index of >7 according to Pederson's scale and a degree of IV (complex procedures) on a modified version of Parant's scale.
Who cannot join
- -
About this study
Official title: Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery: a Randomized, Split-mouth, Placebo-controller, Double-blind Clinical Trial
Objectives:
The aim of this study was to determine the effectiveness of preoperative administration of single-dose of paracetamol-codeine, in the relieving of acute post-operative pain after the surgical removal of an impacted mandibular third molar.
Read more
Materials and Methods:
The study cohort consisted of 32 Caucasian outpatients, giving a total of 64 bilateral symmetrical impacted mandibles. Patients were randomized in two experimental groups to receive a preoperative oral dose of paracetamol-codeine (analgesic group) or a placebo (placebo group) at the first and second surgeries. Study participants were asked to record pain intensity scores during the operation and the next 2 days, the time of the first request for rescue analgesic, and the total number of postoperative-supplement paracetamol-codeine tablets.
- Being tested
- Paracetamol Codeine, Placebo Oral Tablet
- Keywords
- postoperative pain, paracetamol, codeine, tooth extractions, analgesia, premedication
- 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.
Paracetamol CodeineDrug
preoperative administration
Placebo Oral TabletDrug
preoperative administration
| Study group | Role | What they receive |
|---|---|---|
| analgesic group | Active comparator | preoperative oral dose of paracetamol-codeine Receives: Drug: Paracetamol Codeine |
| placebo group | Placebo comparator | preoperative placebo (starch) Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Measured: All study participants were asked to record the pain intensity score at 1:00 pm during the operative day
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Measured: All study participants were asked to record the pain intensity score at 6:00 pm during the operative day
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Measured: All study participants were asked to record the pain intensity score at 11:00 pm during the operative day
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Measured: All study participants were asked to record the pain intensity score at 8:00 am during the 2th day after surgery
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Measured: All study participants were asked to record the pain intensity score at 1:00 pm during the 2th day after surgery
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Measured: All study participants were asked to record the pain intensity score at 6:00 pm during the 2th day after surgery
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Measured: All study participants were asked to record the pain intensity score at 11:00 pm during the 2th day after surgery
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Measured: All study participants were asked to record the pain intensity score at 8:00 am during the 3th day after surgery
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Measured: All study participants were asked to record the pain intensity score at 1:00 pm during the 3th day after surgery
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Measured: All study participants were asked to record the pain intensity score at 6:00 pm during the 3th day after surgery
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Measured: All study participants were asked to record the pain intensity score at 11:00 pm during the 3th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start21 Feb 2013
- Primary completion20 Sep 2015
- Study completion10 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for To Control Pain After Third Molar SurgeryStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, split-mouth, placebo-controlled, double-blind clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Paola Cristalli, University of Roma La Sapienza
- Investigators
- Maria Paola Cristalli, DDS, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03049878
- Sponsor's protocol ID
- 2704/21.02.2013
- Status last verified
- Feb 2017
- First submitted
- 24 Jan 2017
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cristalli MP, La Monaca G, De Angelis C, Pranno N, Annibali S. Efficacy of Preoperative Administration of Paracetamol-Codeine on Pain following Impacted Mandibular Third Molar Surgery: A Randomized, Split-Mouth, Placebo-Controlled, Double-Blind Clinical Trial. Pain Res Manag. 2017;2017:9246352. doi: 10.1155/2017/9246352. Epub 2017 Feb 23.
PubMed 28325960
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery: a Randomized, Split-mouth, Placebo-controller, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT03049878
- Acronym / sponsor ID
- 2704/21.02.2013
- Keywords
- postoperative pain, paracetamol, codeine, tooth extractions, analgesia, premedication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 21 Feb 2013 (actual)
- Primary completion
- 20 Sep 2015 (actual)
- Study completion
- 10 Sep 2016 (actual)
- First posted
- 10 Feb 2017 (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.
Objectives:
The aim of this study was to determine the effectiveness of preoperative administration of single-dose of paracetamol-codeine, in the relieving of acute post-operative pain after the surgical removal of an impacted mandibular third molar.
Materials and Methods:
The study cohort consisted of 32 Caucasian outpatients, giving a total of 64 bilateral symmetrical impacted mandibles. Patients were randomized in two experimental groups to receive a preoperative oral dose of paracetamol-codeine (analgesic group) or a placebo (placebo group) at the first and second surgeries. Study participants were asked to record pain intensity scores during the operation and the next 2 days, the time of the first request for rescue analgesic, and the total number of postoperative-supplement paracetamol-codeine tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, split-mouth, placebo-controlled, double-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| analgesic group | Active comparator | Drug: Paracetamol Codeinepreoperative oral dose of paracetamol-codeine |
| placebo group | Placebo comparator | Drug: Placebo Oral Tabletpreoperative placebo (starch) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- absence of systemic pathologies (ASA class I);
- non-smoker;
- not pregnant or lactating;
- good oral hygiene;
- no drug consumption for 10 days before the operation;
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Paracetamol Codeinepreoperative administration | Drug | analgesic group |
| Placebo Oral Tabletpreoperative administration | Drug | placebo group |
Primary outcome
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.
Time frame: All study participants were asked to record the pain intensity score at 1:00 pm during the operative day
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.
Time frame: All study participants were asked to record the pain intensity score at 6:00 pm during the operative day
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.
Time frame: All study participants were asked to record the pain intensity score at 11:00 pm during the operative day
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
Time frame: All study participants were asked to record the pain intensity score at 8:00 am during the 2th day after surgery
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
Time frame: All study participants were asked to record the pain intensity score at 1:00 pm during the 2th day after surgery
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
Time frame: All study participants were asked to record the pain intensity score at 6:00 pm during the 2th day after surgery
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.
Time frame: All study participants were asked to record the pain intensity score at 11:00 pm during the 2th day after surgery
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
Time frame: All study participants were asked to record the pain intensity score at 8:00 am during the 3th day after surgery
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
Time frame: All study participants were asked to record the pain intensity score at 1:00 pm during the 3th day after surgery
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
Time frame: All study participants were asked to record the pain intensity score at 6:00 pm during the 3th day after surgery
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.
Time frame: All study participants were asked to record the pain intensity score at 11:00 pm during the 3th day after surgery
The primary outcome of the study was the post-operative pain. Before surgery, patients were instructed to complete the Numerical Rating Scale-11 (NRS-11), which consisted of an interval scale ranging from 0 ("no pain") to 10 ("maximum pain")
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 10 Feb 2017.
- Derived from this study: PubMed 28325960Cristalli MP, La Monaca G, De Angelis C, Pranno N, Annibali S. Efficacy of Preoperative Administration of Paracetamol-Codeine on Pain following Impacted Mandibular Third Molar Surgery: A Randomized, Split-Mouth, Placebo-Controlled, Double-Blind Clinical Trial. Pain Res Manag. 2017;2017:9246352. doi: 10.1155/2017/9246352. Epub 2017 Feb 23.
- Individual participant dataSharing planned: No
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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.
Maria Paola Cristalli, DDS principal investigator
University of Roma La Sapienza
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paracetamol Codeine in people with To Control Pain After Third Molar Surgery, run by University of Roma La Sapienza.
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 9 inclusion and 1 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 10 Feb 2017. 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.
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?
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day. (time frame: All study participants were asked to record the pain intensity score at 1:00 pm during the operative day). The study lists 11 primary outcomes in all. 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 NCT03049878, which also lists 1 linked publication.
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 10 Feb 2017.