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Objectives:
The aim of this study was to determine the effectiveness of preoperative administration of single-dose of paracetamol-codeine, in the relieving of acute post-operative pain after the surgical removal of an impacted mandibular third molar.
Materials and Methods:
The study cohort consisted of 32 Caucasian outpatients, giving a total of 64 bilateral symmetrical impacted mandibles. Patients were randomized in two experimental groups to receive a preoperative oral dose of paracetamol-codeine (analgesic group) or a placebo (placebo group) at the first and second surgeries. Study participants were asked to record pain intensity scores during the operation and the next 2 days, the time of the first request for rescue analgesic, and the total number of postoperative-supplement paracetamol-codeine tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| analgesic group | Active Comparator | preoperative oral dose of paracetamol-codeine |
|
| placebo group | Placebo Comparator | preoperative placebo (starch) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol Codeine | Drug | preoperative administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day. | The primary outcome of the study was the post-operative pain. 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) during the operative day. | The primary outcome of the study was the post-operative pain. 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 6:00 pm during the operative day |
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day. | The primary outcome of the study was the post-operative pain. 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 11:00 pm during the operative day |
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery. | The primary outcome of the study was the post-operative pain. 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 8:00 am during the 2th day after surgery |
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients using rescue therapy | Number of patients using rescue therapy during 3 days after surgery | Number of patients using rescue therapy on the same day from the end of the surgery and during 2 days after operative days |
| Time of analgesic medication |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Paola Cristalli, DDS | University of Roma La Sapienza | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28325960 | Derived | Cristalli MP, La Monaca G, De Angelis C, Pranno N, Annibali S. Efficacy of Preoperative Administration of Paracetamol-Codeine on Pain following Impacted Mandibular Third Molar Surgery: A Randomized, Split-Mouth, Placebo-Controlled, Double-Blind Clinical Trial. Pain Res Manag. 2017;2017:9246352. doi: 10.1155/2017/9246352. Epub 2017 Feb 23. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C526278 | acetaminophen, codeine drug combination |
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A randomized, split-mouth, placebo-controlled, double-blind clinical trial
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| Placebo Oral Tablet |
| Drug |
preoperative administration |
|
The primary outcome of the study was the post-operative pain. 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 2th day after surgery |
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery. | The primary outcome of the study was the post-operative pain. 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 6:00 pm during the 2th day after surgery |
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery. | The primary outcome of the study was the post-operative pain. 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 11:00 pm during the 2th day after surgery |
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery. | The primary outcome of the study was the post-operative pain. 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 8:00 am during the 3th day after surgery |
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery. | The primary outcome of the study was the post-operative pain. 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 3th day after surgery |
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery. | The primary outcome of the study was the post-operative pain. 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 6:00 pm during the 3th day after surgery |
| Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery. | The primary outcome of the study was the post-operative pain. 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 11:00 pm during the 3th day after surgery |
Time elapsed from the end of surgery until the first intake of analgesic medication (minutes) |
| Time elapsed from the end of surgery until the first intake of analgesic medication on the same day of the surgery |
| Number of paracetamol-codeine tablets | Total number of paracetamol-codeine tablets with the same formulation taken by the patient in relation to the pain symptoms | Number of paracetamol-codeine tablets taken by the patients during the 3 days after surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |