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Completed

NCT Number: NCT00406679

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

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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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Dental Hospital of Manchester, Manchester, England, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paracetamol (acetaminophen) solution experimental

Drug

1 gm IV

Other names: paracetamol, acetaminophen

paracetamol (acetaminophen) solution commercial

Drug

1 gm IV

Other names: paracetamol, acetaminophen

Placebo

Drug

equivalent volume IV 0.9% sodium chloride (equivalent volume)

Other names: sodium chloride, saline

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Official study title

Single-Dose Comparison of the Analgesic Efficacy, Safety and Tolerability of Two Paracetamol 1%-Containing Solutions and Placebo in a Post-Surgical Dental Pain Model

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 4, 2006
Registry last updated
Aug 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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