Clinical trial NCT04730297: Comparative Analgesic Effects of Paracetamol/Codeine and Ibuprofen on Pain After Third Molar Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: To Control Pain After Third Molar Surgery
Keywords: postsurgical dental pain
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a single-center, 2-stage, prospective, randomized, triple-blind parallel-group, placebo-controlled, clinical trial
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
timeFrame: All study participants were asked to record the pain intensity score at 1:00 pm during the operative day]
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
timeFrame: All study participants were asked to record the pain intensity score at 6:00 pm during the operative day]
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
timeFrame: All study participants were asked to record the pain intensity score at 11:00 pm during the operative day]
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
timeFrame: All study participants were asked to record the pain intensity score at 8:00 am during the 2th day after surgery]
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
timeFrame: All study participants were asked to record the pain intensity score at 1:00 pm during the 2th day after surgery]
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
timeFrame: All study participants were asked to record the pain intensity score at 6:00 pm during the 2th day after surgery]
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
timeFrame: All study participants were asked to record the pain intensity score at 11:00 pm during the 2th day after surgery]
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
timeFrame: All study participants were asked to record the pain intensity score at 8:00 am during the 3th day after surgery]
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
timeFrame: All study participants were asked to record the pain intensity score at 1:00 pm during the 3th day after surgery]
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
timeFrame: All study participants were asked to record the pain intensity score at 6:00 pm during the 3th day after surgery]
measure: Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11)
timeFrame: All study participants were asked to record the pain intensity score at 11:00 pm during the 3th day after surgery]
Secondary outcomes:
measure: Number of patients requiring rescue therapy
timeFrame: until 12-hours after surgery and over extra two days
measure: first postoperative use of analgesics
timeFrame: until 12-hours after surgery
measure: total postoperative use of analgesics
timeFrame: until 12-hours after surgery and over extra two days
Other outcomes:
measure: Compare the efficacy of the same drugs
timeFrame: up to 48 hours after stage 1
Locations:
city: Roma
country: Italy
facility: Maria Paola Cristalli
Study officials:
affiliation: University of Roma La Sapienza
name: Maria Paola Cristalli, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.