Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2001-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study involves approximately 200 patients designed to evaluate the efficacy and safety of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pain Control Following Third Molar Surgery

NCT06514222

Post Operative Pain Impacted Third Molar Tooth

ACTIVE_NOT_RECRUITING EARLY_PHASE1

Efficacy and Safety of DIT112 in the Treatment of Moderate to Severe Pain After Dental Surgery for the Extraction of Impacted Third Molars

NCT06237231

Moderate Pain Severe Pain

NOT_YET_RECRUITING PHASE3

Safety and Efficacy of Intranasal Ketamine for the Treatment of Postoperative Dental Pain

NCT00488787

Pain, Postoperative

COMPLETED PHASE2

Study of Long-Acting Acetaminophen in Postoperative Dental Pain

NCT01960114

Dental Pain

COMPLETED PHASE2

Towards Predicting the Analgesic Response to Ibuprofen Following Third-molar Extraction

NCT03893175

Impacted Third Molar Tooth Pain, Acute

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Diagnosis and Main Criteria for Inclusion: Dental outpatients undergoing the removal of 3 or more third molars (2 of which were required to be mandibular and both must be bony impacted third molars).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-Operative Pain Third Molar Extraction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

4

Intravenous morphine

Group Type ACTIVE_COMPARATOR

Intravenous morphine

Intervention Type DRUG

Intravenous morphine 7.5 mg

1

Intranasal morphine 7.5 mg

Group Type EXPERIMENTAL

Intranasal morphine 7.5 mg

Intervention Type DRUG

Intranasal morphine 7.5 mg

2

Intranasal morphine 15 mg

Group Type EXPERIMENTAL

Intranasal Morphine 15 mg

Intervention Type DRUG

Intranasal Morphine 15 mg

3

Oral morphine 60 mg

Group Type ACTIVE_COMPARATOR

Immediate Release Oral Morphine 60 mg

Intervention Type DRUG

Immediate Release Oral Morphine 60 mg

5

Intranasal placebo

Group Type PLACEBO_COMPARATOR

Intranasal Placebo

Intervention Type DRUG

Intranasal placebo

6

Oral placebo

Group Type PLACEBO_COMPARATOR

Oral placebo

Intervention Type DRUG

Oral placebo

7

Intravenous placebo

Group Type PLACEBO_COMPARATOR

Intravenous placebo

Intervention Type DRUG

Intravenous placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intranasal Placebo

Intranasal placebo

Intervention Type DRUG

Intranasal Morphine 15 mg

Intervention Type DRUG

Immediate Release Oral Morphine 60 mg

Intervention Type DRUG

Intravenous morphine

Intravenous morphine 7.5 mg

Intervention Type DRUG

Intranasal morphine 7.5 mg

Intervention Type DRUG

Oral placebo

Intervention Type DRUG

Intravenous placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female 18-40 years of age
* Surgical extraction of at least three or more third molars (two must be mandibular and both must be bony impacted third molars)
* Moderate or severe pain within 6 hours of completion of surgery

Exclusion Criteria

* Other oral surgical procedures during the same session except the removal of supernumerary third molars
* Evidence of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety
* Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated
* Allergy to shellfish

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No