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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00406679

Enrollment

135

Registered

2006-12-04

Start date

2006-11-30

Completion date

2007-10-31

Last updated

2011-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

pain, postoperative, surgery, oral, surgery, dental

Brief summary

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).

Interventions

DRUGParacetamol (acetaminophen) solution experimental

1 gm IV

DRUGparacetamol (acetaminophen) solution commercial

1 gm IV

DRUGplacebo

equivalent volume IV 0.9% sodium chloride (equivalent volume)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026