## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** R-01270-A015
#### Organization
**Class:** INDUSTRY
**Full Name:** Baxter Healthcare Corporation
#### Secondary ID Infos
**ID:** EudraCT2005-005575-14
### Status Module
#### Completion Date
**Date:** 2007-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-08-11

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-08-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-10

**Type:** ACTUAL

#### Start Date
**Date:** 2006-11

**Status Verified Date:** 2011-08

#### Study First Post Date
**Date:** 2006-12-04
**Type:** ESTIMATED
**Study First Submit Date:** 2006-11-29
**Study First Submit QC Date:** 2006-11-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Baxter Healthcare Corporation

#### Responsible Party

**Old Name Title:** Keyvan Tadjalli Mehr, MD

**Old Organization:** Baxter Healthcare Corporation

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- Pain, Postoperative

**Keywords:**

- pain, postoperative

- surgery, oral

- surgery, dental

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 135

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Paracetamol (acetaminophen) solution experimental

**Label:** 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: placebo

**Label:** 2

**Type:** PLACEBO_COMPARATOR

#### Arm Group 3

**Intervention Names:**

- Drug: paracetamol (acetaminophen) solution commercial

**Label:** 3

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** 1 gm IV

**Name:** Paracetamol (acetaminophen) solution experimental

**Other Names:**

- paracetamol

- acetaminophen

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 3

**Description:** 1 gm IV

**Name:** paracetamol (acetaminophen) solution commercial

**Other Names:**

- paracetamol

- acetaminophen

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- 2

**Description:** equivalent volume IV 0.9% sodium chloride (equivalent volume)

**Name:** placebo

**Other Names:**

- sodium chloride

- saline

**Type:** DRUG

### Eligibility Module

**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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Manchester

**Country:** United Kingdom

**Facility:** University Dental Hospital of Manchester

**State:** England

**Location 2:**

**City:** Cardiff

**Country:** United Kingdom

**Facility:** University Dental Hospital NHS Trust Cardiff

**State:** Wales

#### Overall Officials

**Official 1:**

**Affiliation:** Baxter Healthcare Corporation

**Name:** Keyvan Tadjalli-Mehr, MD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Pain, Postoperative

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M16853

- Name: Toothache

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Ancestors

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000058633

- Term: Antipyretics

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

- Abbrev: Antipy

- Name: Antipyretics

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: HIGH

- As Found: Procedure

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M2340

- Name: Acetaminophen

- Relevance: HIGH

- As Found: Compared

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M29176

- Name: Antipyretics

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000082

- Term: Acetaminophen

- ID: D000019999

- Term: Pharmaceutical Solutions

### Misc Info Module

- Version Holder: 2024-05-24
