To Control Pain After Third Molar SurgeryPhase 4NCT04730297
Comparative Analgesic Effects of Paracetamol/Codeine and Ibuprofen on Pain After Third Molar Surgery
A Phase 4 study testing paracetamol 500 mg plus codeine 30 mg preoperative administration and ibuprofen 400 mg preoperative administration in people with To Control Pain After Third Molar Surgery, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
To compare analgesic effects of preoperative administration of paracetamol 500 milligram plus codeine 30 milligram in single-tablet and effervescent formulation to ibuprofen 400 milligram, and placebo in the management of moderate to severe postoperative pain after mandibular third molar surgery. Read more about this study
- Who is it for?
- Ages 15 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- To Control Pain After Third Molar Surgery
- What is being tested?
- paracetamol 500 mg plus codeine 30 mg preoperative administration and ibuprofen 400 mg preoperative administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2018to 14 Oct 2020
- 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 15 to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy status (ASA class I);
- nonsmoker;
- not pregnant or breastfeeding;
- no medication consumption in the past 21 days;
- good oral hygiene;
- bony impaction of one mandibular third molars;
- the presence of the first and second molars;
- compliance to cooperate with the research protocol.
Who cannot join
- chronic systemic disease;
- medications with potential interaction to paracetamol-codeine or ibuprofen;
- a history of intolerance or hypersensitivity to the study drugs;
- any pre-existing pain and acute inflammatory or infectious conditions; - inability to understand or perform the study procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analgesic Effects of Preoperative Administration of Paracetamol (Acetominophen) 500 mg Plus Codeine 30 mg and Ibuprofen 400 mg on Pain After Third Molar Surgery
To compare analgesic effects of preoperative administration of paracetamol 500 milligram plus codeine 30 milligram in single-tablet and effervescent formulation to ibuprofen 400 milligram, and placebo in the management of moderate to severe postoperative pain after mandibular third molar surgery.
Read the detailed description
Materials and methods: One hundred twenty healthy outpatients aged 15 to 29 years undergoing surgical removal of one bony impacted mandibular third molar were enrolled in this, single-center, prospective, randomized, triple-blind parallel-group, placebo-controlled, clinical trial. Study participants were randomly assigned to three treatment arms. According to the concealed allocation, each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg (group A), ibuprofen 400 mg (group B) or placebo (group C). Rescue therapy allowed in the postoperative period was paracetamol 500 mg plus codeine 30 mg in groups A and C and ibuprofen 400 mg in group B. Patients recorded on Numerical Rating Scale-11 (NRS-11) the pain intensity, total number of postoperative-supplement medications and time of the first intake, until 12-hours after surgery and over extra two days
- Being tested
- paracetamol 500 mg plus codeine 30 mg preoperative administration, ibuprofen 400 mg preoperative administration, Placebo oral tablet preoperative administration
- Keywords
- postsurgical dental pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamol 500 mg plus codeine 30 mg preoperative administrationDrug
Also called GROUP A
each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg
ibuprofen 400 mg preoperative administrationDrug
Also called GROUP B
each patient 30 minutes before surgery received ibuprofen 400 mg
Placebo oral tablet preoperative administrationDrug
Also called GROUP C
each patient 30 minutes before surgery received placebo
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol/codeine Group A | Active comparator | analgesic group preoperative oral dose of paracetamol 500 mg plus codeine 30 mg Receives: Drug: paracetamol 500 mg plus codeine 30 mg preoperative administration |
| Ibuprofen Group B | Active comparator | analgesic group preoperative oral dose of ibuprofen 400 mg Receives: Drug: ibuprofen 400 mg preoperative administration |
| Placebo Group C | Placebo comparator | Placebo group preoperative placebo Receives: Drug: Placebo oral tablet preoperative administration |
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)
In stage 1, the objective was to misure the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day. 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)
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single
dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.
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)
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.
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)
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo
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)
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo
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)
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo
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)
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.
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)
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.
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)
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.
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)
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.
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)
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.
Measured: All study participants were asked to record the pain intensity score at 11:00 pm during the 3th day after surgery]
Secondary outcomes (3)
Number of patients requiring rescue therapy
outcomes involved the number of patients requiring rescue therapy
Measured: until 12-hours after surgery and over extra two days
first postoperative use of analgesics
time of the first intake
Measured: until 12-hours after surgery
total postoperative use of analgesics
total amount of additional medication
Measured: until 12-hours after surgery and over extra two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start1 Jan 2018
- Primary completion4 Sep 2020
- Study completion14 Oct 2020
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 single-center, 2-stage, prospective, randomized, triple-blind parallel-group, placebo-controlled, clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 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, PhD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730297
- Sponsor's protocol ID
- 2704/2013
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
La Monaca G, Pranno N, Annibali S, Polimeni A, Pompa G, Vozza I, Cristalli MP. COMPARATIVE ANALGESIC EFFECTS OF SINGLE-DOSE PREOPERATIVE ADMINISTRATION OF PARACETAMOL (ACETAMINOPHEN) 500 mg PLUS CODEINE 30 mg AND IBUPROFEN 400 mg ON PAIN AFTER THIRD MOLAR SURGERY. J Evid Based Dent Pract. 2021 Dec;21(4):101611. doi: 10.1016/j.jebdp.2021.101611. Epub 2021 Jul 10.
PubMed 34922726
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analgesic Effects of Preoperative Administration of Paracetamol (Acetominophen) 500 mg Plus Codeine 30 mg and Ibuprofen 400 mg on Pain After Third Molar Surgery
- ClinicalTrials.gov ID
- NCT04730297
- Acronym / sponsor ID
- 2704/2013
- Keywords
- postsurgical dental pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 14 Oct 2020 (actual)
- First posted
- 29 Jan 2021 (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 compare analgesic effects of preoperative administration of paracetamol 500 milligram plus codeine 30 milligram in single-tablet and effervescent formulation to ibuprofen 400 milligram, and placebo in the management of moderate to severe postoperative pain after mandibular third molar surgery.
Detailed description
Materials and methods: One hundred twenty healthy outpatients aged 15 to 29 years undergoing surgical removal of one bony impacted mandibular third molar were enrolled in this, single-center, prospective, randomized, triple-blind parallel-group, placebo-controlled, clinical trial. Study participants were randomly assigned to three treatment arms. According to the concealed allocation, each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg (group A), ibuprofen 400 mg (group B) or placebo (group C). Rescue therapy allowed in the postoperative period was paracetamol 500 mg plus codeine 30 mg in groups A and C and ibuprofen 400 mg in group B. Patients recorded on Numerical Rating Scale-11 (NRS-11) the pain intensity, total number of postoperative-supplement medications and time of the first intake, until 12-hours after surgery and over extra two days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- a single-center, 2-stage, prospective, randomized, triple-blind parallel-group, placebo-controlled, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Paracetamol/codeine Group A | Active comparator | Drug: paracetamol 500 mg plus codeine 30 mg preoperative administrationanalgesic group preoperative oral dose of paracetamol 500 mg plus codeine 30 mg |
| Ibuprofen Group B | Active comparator | Drug: ibuprofen 400 mg preoperative administrationanalgesic group preoperative oral dose of ibuprofen 400 mg |
| Placebo Group C | Placebo comparator | Drug: Placebo oral tablet preoperative administrationPlacebo group preoperative placebo |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- healthy status (ASA class I);
- nonsmoker;
- not pregnant or breastfeeding;
- no medication consumption in the past 21 days;
- good oral hygiene;
Key exclusion criteria (4 listed)
- chronic systemic disease;
- medications with potential interaction to paracetamol-codeine or ibuprofen;
- a history of intolerance or hypersensitivity to the study drugs;
- any pre-existing pain and acute inflammatory or infectious conditions; - inability to understand or perform the study procedure.
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 500 mg plus codeine 30 mg preoperative administrationAlso: GROUP Aeach patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg | Drug | Paracetamol/codeine Group A |
| ibuprofen 400 mg preoperative administrationAlso: GROUP Beach patient 30 minutes before surgery received ibuprofen 400 mg | Drug | Ibuprofen Group B |
| Placebo oral tablet preoperative administrationAlso: GROUP Ceach patient 30 minutes before surgery received placebo | Drug | Placebo Group C |
Primary outcome
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
Time frame: All study participants were asked to record the pain intensity score at 1:00 pm during the operative day]
In stage 1, the objective was to misure the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day. 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)
Time frame: All study participants were asked to record the pain intensity score at 6:00 pm during the operative day]
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
Time frame: All study participants were asked to record the pain intensity score at 11:00 pm during the operative day]
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
Time frame: All study participants were asked to record the pain intensity score at 8:00 am during the 2th day after surgery]
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
Time frame: All study participants were asked to record the pain intensity score at 1:00 pm during the 2th day after surgery]
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
Time frame: All study participants were asked to record the pain intensity score at 6:00 pm during the 2th day after surgery]
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
Time frame: All study participants were asked to record the pain intensity score at 11:00 pm during the 2th day after surgery]
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
Time frame: All study participants were asked to record the pain intensity score at 8:00 am during the 3th day after surgery]
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
Time frame: All study participants were asked to record the pain intensity score at 1:00 pm during the 3th day after surgery]
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
Time frame: All study participants were asked to record the pain intensity score at 6:00 pm during the 3th day after surgery]
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
Time frame: All study participants were asked to record the pain intensity score at 11:00 pm during the 3th day after surgery]
In stage 1, the objective was to compare the efficacy on pain and tolerability of a single dose of paracetamol plus codeine, ibuprofen, or placebo in the operative day.
3 secondary outcomes
Number of patients requiring rescue therapy
Time frame: until 12-hours after surgery and over extra two days
first postoperative use of analgesics
Time frame: until 12-hours after surgery
total postoperative use of analgesics
Time frame: until 12-hours after surgery and over extra two days
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 29 Jan 2021.
- Derived from this study: PubMed 34922726La Monaca G, Pranno N, Annibali S, Polimeni A, Pompa G, Vozza I, Cristalli MP. COMPARATIVE ANALGESIC EFFECTS OF SINGLE-DOSE PREOPERATIVE ADMINISTRATION OF PARACETAMOL (ACETAMINOPHEN) 500 mg PLUS CODEINE 30 mg AND IBUPROFEN 400 mg ON PAIN AFTER THIRD MOLAR SURGERY. J Evid Based Dent Pract. 2021 Dec;21(4):101611. doi: 10.1016/j.jebdp.2021.101611. Epub 2021 Jul 10.
- Individual participant dataSharing planned: No
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Acute Pain, Molar
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, PhD principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing paracetamol 500 mg plus codeine 30 mg preoperative administration and ibuprofen 400 mg preoperative administration in people with To Control Pain After Third Molar Surgery, run by University of Roma La Sapienza at 1 site in Italy.
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 8 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 29 Jan 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 Italy. 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?
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) (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 NCT04730297, 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 29 Jan 2021.