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Clinical Trials/NCT03049878
NCT03049878CompletedPhase 4

Efficacy of Preoperative Administration of Paracetamol-codeine on Pain Following Impacted Mandibular Third Molar Surgery: a Randomized, Split-mouth, Placebo-controller, Double-blind Clinical Trial

University of Roma La Sapienza0 sites32 target enrollmentStarted: February 21, 2013Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
32
Primary Endpoint
Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Not provided

Arms & Interventions

analgesic group

Active Comparator

preoperative oral dose of paracetamol-codeine

Intervention: Paracetamol Codeine (Drug)

placebo group

Placebo Comparator

preoperative placebo (starch)

Intervention: Placebo Oral Tablet (Drug)

Outcomes

Primary Outcomes

Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the operative day.

Time Frame: All study participants were asked to record the pain intensity score at 11:00 pm 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")

Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 2th day after surgery.

Time Frame: All study participants were asked to record the pain intensity score at 11:00 pm 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")

Pain measurement assessed with the Numerical Rating Scale-11 (NRS-11) during the 3th day after surgery.

Time Frame: All study participants were asked to record the pain intensity score at 11:00 pm 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")

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Roma La Sapienza
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maria Paola Cristalli

DDS PhD, Clinical Professor

University of Roma La Sapienza

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