Effect of local application of morphine for pain management in palliative cancer patients.

Effect of topical morphine for pain management in patients with malignant wounds in a Palliative Care setting in India: A Randomized Controlled Phase II Trial. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075438

Enrollment

165

Registered

2024-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Arm Topical: Topical morphine + breakthrough dose [BTP] doses as required for pain management within the stratum. Intervention2: Arm SC+Topical: Oral opioids + Topical morphine Control

Eligibility

Inclusion criteria

Inclusion criteria: 1) Cancer patients who have malignant fungating wound. 2) Pain score 4 to 10 on a numerical rating scale.

Exclusion criteria

Exclusion criteria: 1) Hemodynamically unstable /cognitively unstable 2) Maggots in the malignant fungating wound 3] Known allergic reaction to morphine. 4) Opioid contraindicated 5) Patients who have orocutaneous fistula and intraoral wounds

Design outcomes

Primary

Measure	Time frame
To compare the change in pain score between the three arms.Timepoint: 1. Pre wound dressing- NRS Score. 2. After one hour of post wound dressing- morning [T1] and evening [T2] on day 1 and day 2	—

Secondary

Measure	Time frame
To compare the requirement of opioids in 24 hours by calculating daily OME requirement and document adverse events during the study period.Timepoint: After one hour of post wound dressing on day 1 and day 2;To evaluate the correlation between malignant fungating wound size and the effect of topical morphine by comparing the reduction in pain scores in both strata. Timepoint: After one hour of post wound dressing on day 1 and day 2;Measure the apparent onset of the effectiveness of topical morphine post-dressing according to the patient observation or experience by calculating the time difference between dose administration and the apparent onset of reduction in pain.Timepoint: After one hour of post wound dressing on day 1 and day 2	—

Measure

Time frame

To compare the requirement of opioids in 24 hours by calculating daily OME requirement and document adverse events during the study period.Timepoint: After one hour of post wound dressing on day 1 and day 2;To evaluate the correlation between malignant fungating wound size and the effect of topical morphine by comparing the reduction in pain scores in both strata. Timepoint: After one hour of post wound dressing on day 1 and day 2;Measure the apparent onset of the effectiveness of topical morphine post-dressing according to the patient observation or experience by calculating the time difference between dose administration and the apparent onset of reduction in pain.Timepoint: After one hour of post wound dressing on day 1 and day 2

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Countries

India

Contacts

Public ContactDr Shamali Poojary

Tata Memorial Hospital

shamalipoojary8@gmail.com02224174271

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026