To Control Pain After Third Molar Surgery
Conditions
Keywords
postsurgical dental pain
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
Interventions
DRUGibuprofen 400 mg preoperative administration
each patient 30 minutes before surgery received ibuprofen 400 mg
DRUGparacetamol 500 mg plus codeine 30 mg preoperative administration
each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg
DRUGPlacebo oral tablet preoperative administration
each patient 30 minutes before surgery received placebo
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
a single-center, 2-stage, prospective, randomized, triple-blind parallel-group, placebo-controlled, clinical trial
Eligibility
Sex/Gender
ALL
Age
15 Years to 29 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients requiring rescue therapy | until 12-hours after surgery and over extra two days | outcomes involved the number of patients requiring rescue therapy |
| first postoperative use of analgesics | until 12-hours after surgery | time of the first intake |
| total postoperative use of analgesics | until 12-hours after surgery and over extra two days | total amount of additional medication |
Other
| Measure | Time frame | Description |
|---|---|---|
| Compare the efficacy of the same drugs | up to 48 hours after stage 1 | Patients recorded on Numerical Rating Scale-11 (NRS-11) the pain intensity |
Countries
Italy
Outcome results
None listed