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

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Baxter

Status and phase

Completed
Phase 3

Conditions

Pain, Postoperative

Treatments

Drug: Paracetamol (acetaminophen) solution experimental
Drug: placebo
Drug: paracetamol (acetaminophen) solution commercial

Study type

Interventional

Funder types

Industry

Identifiers

NCT00406679
R-01270-A015
EudraCT2005-005575-14

Details and patient eligibility

About

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).

Enrollment

135 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

135 participants in 3 patient groups, including a placebo group

1
Experimental group
Treatment:
Drug: Paracetamol (acetaminophen) solution experimental
2
Placebo Comparator group
Treatment:
Drug: placebo
3
Active Comparator group
Treatment:
Drug: paracetamol (acetaminophen) solution commercial

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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