Tramadol/Paracetamol (Zaldiar) compared with oxycodone and paracetamol for the management of post-operative pain following major surgery in gynaecology oncology patients

Tramadol/Paracetamol (Zaldiar) compared with oxycodone and paracetamol for the management of post-operative pain following major surgery in gynaecology oncology: comparison of post-operative nausea and constipation

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001341314

Enrollment

186

Registered

2017-09-21

Start date

2018-11-01

Completion date

2019-07-31

Last updated

2018-09-03

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

Conditions

None listed

Brief summary

This study aims to investigate the efficacy and safety of tramadol/paracetamol combined dosing compared with paracetamol and oxycodone for pain management following major surgery in gynaecology oncology patients. Who is it for? You may be eligible to join this study if you are a female aged 18 years or more who is planned for major surgery for either benign or malignant tumours in gynaecological oncology. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will take oral Tramadol/paracetamol for post-operative pain management in the week following hospital discharge. Participants in the other group will take oral paracetamol and oxycodone in the week following discharge. All participants will be followed-up for 28 days in order to evaluate post-operative nausea, constipation, adverse events, hospital re-admission rates, and efficacy of pain relief. We hope to determine whether Tramadol / paracetamol is a safe, effective, and well-tolerated option for post-operative pain management.

Interventions

• Group A (intervention group) Patients randomised to group A will have the following post-operative oral medication, once they are deemed suitable for discharge oral analgesia by the treating team: o Tramadol/paracetamol orally 37.5 mg/325 mg, two tablets 4 times per day (to continue for one week on discharge) Patients will be asked on day 7 post discharge how many tablets they have not used in that period

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• Patients planned for major surgery for both benign and malignant in the department of gynaecological oncology will be approached for recruitment into the study. • Aged 18 or over • English speaking • Willingness to give written informed consent, and willingness to participate to and comply with the study.

Exclusion criteria

• Non-English speaking or unable to provide informed consent • Patients with a documented allergy or contraindication to any of the drugs included in group A or B • Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.

Outcome results