Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery

Randomized, Double-Blind, Placebo and Comparator-Controlled, Dose-Response Trial of the Efficacy and Safety of Intranasal Morphine, Intravenous Morphine and Placebo in Patients With Moderate to Severe Pain Following Orthopedic Surgery

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00388011

Enrollment

187

Registered

2006-10-13

Start date

2005-01-31

Completion date

2005-08-31

Last updated

2008-01-14

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

Conditions

Hallux Valgus

Keywords

Post surgical pain, Bunionectomy, Hammer Toe Syndrome, Morphine

Brief summary

Study designed to evaluate the efficacy and safety of Intranasal (IN) Morphine Nasal Spray (MNS075) 3.75 mg, 7.5 mg, 15 mg, and 30 mg, intravenous (IV) morphine 7.5 mg, or IN placebo in patients with moderate to severe post-surgical pain following orthopedic surgery. After initial dosing, up to six (6) doses of IN MNS075 7.5 mg or 15 mg for up to twenty-four (24) hours will be evaluated. The rescue dose remained the same for each.

Detailed description

Diagnosis and Main Criteria for Inclusion: Healthy adult patients (18 to 76 years old), who scored PS-1 to PS-3 according to the American Society of Anesthesiologists Physical Status Classification System, requiring primary, unilateral, first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair without additional collateral procedures.

Interventions

DRUGIntranasal morphine (MNS075) 30 mg

Intranasal morphine (MNS075) 30 mg

DRUGIntranasal Morphine (MNS075) 3.75 mg

Intranasal Morphine (MNS075) 3.75 mg

DRUGIntravenous Morphine 7.5 mg

Intravenous Morphine 7.5 mg

DRUGIntranasal morphine (MNS075) 7.5 mg

Intranasal morphine (MNS075) 7.5 mg

DRUGIntranasal morphine (MNS075) 15 mg

Intranasal morphine (MNS075) 15 mg

DRUGIntranasal placebo

Intranasal placebo

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 No maximum

Healthy volunteers

Inclusion criteria

* Requires primary unilateral first metatarsal bunionectomy surgery alone or with ipsilateral hammertoe repair under regional anesthesia. The patient requires collateral orthopedic surgical procedures other than ipsilateral hammertoe repair may not be enrolled into the study. * 18 years of age or older * Moderate to severe pain within eight (8) hours following completion of the required bunionectomy surgery

Exclusion criteria

* Allergy to shellfish * Signs 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 Additional Inclusion/

Design outcomes

Primary

Measure	Time frame
VAS Total Pain Relief 0-4 hours (TOTPAR4)	4 hours

Secondary

Measure	Time frame
Other measures of pain relief	Several time points

Outcome results

None listed

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