Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery

NCT03049878 | Completed Phase 4 DMC

• 1 other identifier: 2704/21.02.2013
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

To Control Pain After Third Molar Surgery

Keywords

postoperative pain; paracetamol; codeine; tooth extractions; analgesia; premedication

Outcome Measures

Primary Outcomes (11)

• 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.

  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

Other Outcomes (3)

• Number of patients using rescue therapy

  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

  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

  Number of paracetamol-codeine tablets taken by the patients during the 3 days after surgery

Study Arms (2)

analgesic group

ACTIVE COMPARATOR

preoperative oral dose of paracetamol-codeine

Drug: Paracetamol Codeine

placebo group

PLACEBO COMPARATOR

preoperative placebo (starch)

Drug: Placebo Oral Tablet

Interventions

Paracetamol Codeine DRUG

preoperative administration

analgesic group

Placebo Oral Tablet DRUG

preoperative administration

placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• absence of systemic pathologies (ASA class I);
• non-smoker;
• not pregnant or lactating;
• good oral hygiene;
• no drug consumption for 10 days before the operation;
• bilateral impacted mandibular third molars with comparable position, depth and inclination;
• presence of the first and second molars;
• absence of painful symptoms and associated inflammatory or osteolytic pathologies in a radiographic examination;
• extraction difficulty index of \>7 according to Pederson's scale and a degree of IV (complex procedures) on a modified version of Parant's scale.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Related Publications (1)

• 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.

  PMID: 28325960 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

acetaminophen, codeine drug combination

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Maria Paola Cristalli, DDS

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS PhD, Clinical Professor

Model Details: A randomized, split-mouth, placebo-controlled, double-blind clinical trial

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 10, 2017
• Study Start: February 21, 2013
• Primary Completion: September 20, 2015
• Study Completion: September 10, 2016
• Last Updated: February 10, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share