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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Paracetamol (acetaminophen) solution experimental
paracetamol (acetaminophen) solution commercial
placebo
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring pain, postoperative, surgery, oral, surgery, dental

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Dental Hospital of Manchester
  • University Dental Hospital NHS Trust Cardiff

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 29, 2006
Last Updated
August 10, 2011
Sponsor
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00406679
Brief Title
Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-containing Solutions in Post-Surgical Dental Pain
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
pain, postoperative, surgery, oral, surgery, dental

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Paracetamol (acetaminophen) solution experimental
Other Intervention Name(s)
paracetamol, acetaminophen
Intervention Description
1 gm IV
Intervention Type
Drug
Intervention Name(s)
paracetamol (acetaminophen) solution commercial
Other Intervention Name(s)
paracetamol, acetaminophen
Intervention Description
1 gm IV
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
sodium chloride, saline
Intervention Description
equivalent volume IV 0.9% sodium chloride (equivalent volume)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keyvan Tadjalli-Mehr, MD
Organizational Affiliation
Baxter Healthcare Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University Dental Hospital of Manchester
City
Manchester
State/Province
England
Country
United Kingdom
Facility Name
University Dental Hospital NHS Trust Cardiff
City
Cardiff
State/Province
Wales
Country
United Kingdom

12. IPD Sharing Statement

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

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