NCT04730297|CompletedPhase 4DMC
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Sponsor study identifier
interventional
120
1 country
1
Study Start
January 1, 2018
Actual (reported)Primary Completion
September 4, 2020
Actual (reported)Study Completion
October 14, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 14, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2018
Actual (reported)September 4, 2020
Actual (reported)October 14, 2020
Actual (reported)January 13, 2021
Actual (reported)January 29, 2021
Actual (reported)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")
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.
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.
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
All study participants were asked to record the pain intensity score at 8:00 am during the 2th day after surgery]
Number of patients requiring rescue therapy
until 12-hours after surgery and over extra two days
first postoperative use of analgesics
until 12-hours after surgery
total postoperative use of analgesics
until 12-hours after surgery and over extra two days
Compare the efficacy of the same drugs
up to 48 hours after stage 1
analgesic group preoperative oral dose of paracetamol 500 mg plus codeine 30 mg
analgesic group preoperative oral dose of ibuprofen 400 mg
Placebo group preoperative placebo
each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg
each patient 30 minutes before surgery received ibuprofen 400 mg
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment programme
paracetamol 500 mg plus codeine 30 mg preoperative administration
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordMaria Paola Cristalli
Roma, 00100, Italy
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.
Maria Paola Cristalli, DDS, PhD
University of Roma La Sapienza
120 participants (actual enrollment reported by the registry).
First Submitted
January 13, 2021
First Posted
January 29, 2021
Study Start
January 1, 2018
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
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
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.
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.
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.
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.
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.
All study participants were asked to record the pain intensity score at 11:00 pm during the 3th day after surgery]
each patient 30 minutes before surgery received placebo
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 4, 2020
Actual (reported)Study Completion
October 14, 2020
Actual (reported)Last Updated
January 29, 2021
Record last verified: 2021-01
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Source: ClinicalTrials.gov.
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