A Phase 4 interventional study of paracetamol 500 mg plus codeine 30 mg preoperative administration and ibuprofen 400 mg preoperative administration in To Control Pain After Third Molar Surgery, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 15 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-29.
Sponsored by University of Roma La Sapienza · Phase 4, Interventional, and Treatment
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.
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
University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
analgesic group preoperative oral dose of paracetamol 500 mg plus codeine 30 mg
Drug: paracetamol 500 mg plus codeine 30 mg preoperative administration
analgesic group preoperative oral dose of ibuprofen 400 mg
Drug: ibuprofen 400 mg preoperative administration
Placebo group preoperative placebo
Drug: Placebo oral tablet preoperative administration
each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg
Also known as: GROUP A
each patient 30 minutes before surgery received ibuprofen 400 mg
Also known as: GROUP B
each patient 30 minutes before surgery received placebo
Also known as: GROUP C
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")
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: All study participants were asked to record the pain intensity score at 11:00 pm during the 3th day after surgery]
Number of patients requiring rescue therapy
outcomes involved the number of patients requiring rescue therapy
Time frame: until 12-hours after surgery and over extra two days
first postoperative use of analgesics
time of the first intake
Time frame: until 12-hours after surgery
total postoperative use of analgesics
total amount of additional medication
Time frame: until 12-hours after surgery and over extra two days
Compare the efficacy of the same drugs
Patients recorded on Numerical Rating Scale-11 (NRS-11) the pain intensity
Time frame: up to 48 hours after stage 1
Plan to share: No
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University of Roma La Sapienza