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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230502004

Enrollment

Registered

2023-05-02

Start date

2019-03-12

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

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

Interventions

The participants were receive either 1.5 mg of buccal midazolam solution Both were provided as oral morphine adjuncts in both groups. Patients who were already receiving morphine received 10% of their

Experimental Drug,Active Comparator Drug

Midazolam group,Lorazepam group

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Thailand

Contacts

Public ContactManeethip Srimahakosol

Faculty of Medicine Ramathibodhi Hospital Mahidol University

angledar2@gmail.com66834204191

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026