Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-containing Solutions in Post-Surgical Dental Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-10-31

Brief Summary

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The aim of the study is to evaluate the therapeutic efficacy and safety of two different paracetamol-containing solutions in postoperative dental pain. They will be compared to placebo (a dummy treatment which contains no active ingredient).

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Paracetamol (acetaminophen) solution experimental

Intervention Type DRUG

1 gm IV

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

equivalent volume IV 0.9% sodium chloride (equivalent volume)

3

Group Type ACTIVE_COMPARATOR

paracetamol (acetaminophen) solution commercial

Intervention Type DRUG

1 gm IV

Interventions

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Paracetamol (acetaminophen) solution experimental

1 gm IV

Intervention Type DRUG

paracetamol (acetaminophen) solution commercial

1 gm IV

Intervention Type DRUG

placebo

equivalent volume IV 0.9% sodium chloride (equivalent volume)

Intervention Type DRUG

Other Intervention Names

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paracetamol acetaminophen paracetamol acetaminophen sodium chloride saline

Eligibility Criteria

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Inclusion Criteria

* ASA I or II and scheduled for elective surgical extraction of 1 or more impacted mandibular 3rd molars, at least 1 of which must be a fully or partially impacted mandibular 3rd molar requiring mandibular bone removal.
* Moderate or severe pain within 4 hours after the completion of surgery.

Exclusion Criteria

* Another acute or chronic painful physical condition
* Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well as microsomal enzyme inducers
* Inability to use and understand Visual Analog Scale and Verbal Rating Score

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No