Efficacy of buccal midazolam compared with sublingual lorazepam for reducing dyspnea as adjunct to morphine in palliative cancer patients: A randomized controlled trial

Phase 4

Completed

• Conditions: Cancer patients who were documented as palliative patients; Palliative cancer patients; dyspnea; ESAS-Thai; sublingual Lorazepam; buccal Midazolam; randomized controlled trial

• Registration Number: TCTR20230502004
• Lead Sponsor: Faculty of Medicine Ramathibodhi Hospital Mahidol University

Brief Summary

sing buccal midazolam as an adjuvant to morphine significantly reduced dyspnea scores with a faster onset of action compared to sublingual lorazepam.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-11-18
• Study Start: 2023-05-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Cancer patients who were documented as palliative patients
2.At least 18 years old
3.Able to answer questions from the Thai version of the Edmonton Symptom Assessment Scale (ESAS-Thai)
4.Had a dyspnea score of 3 or higher on the ESAS-dyspnea

Exclusion Criteria

1. Patients with underlying cardiopulmonary conditions, including congestive heart failure, asthma, chronic obstructive pulmonary disease, obstructive sleep apnea, and glaucoma
2. Patients whose oxygen saturation (SpO2) is less than 88%
3. Patients who were on an endotracheal tube or used noninvasive ventilation
4. Patients with a history of benzodiazepine or opioid allergy
5. Patients who were on some medications, including valproate, probenecid, and phenobarbital
6. Participants who consumed alcohol 24 hours before the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the severity of dyspnea, we used the Thai version of the Edmonton Symptom Assessment System (ESAS-Thai) 0, 15, 30, and 60 minutes Thai version of the Edmonton Symptom Assessment System (ESAS-Thai)

Secondary Outcome Measures

Name	Time	Method
anxiety and well-being 0, 15, 30, and 60 minutes Thai version of the Edmonton Symptom Assessment System (ESAS-Thai),respiratory rate, the use of accessory respiratory muscles, the level of oxygen saturation, sedation score scale 0, 15, 30, and 60 minutes Physical examination,side effects 60 minutes including mucosal irritation, nausea, vomiting, and amnesia