The comparison between tramadol and nalbuphine in managing postoperative pain following supratentorial craniotomy; a randomized control trial

Status

Unknown

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250204012

Enrollment

Registered

2025-02-04

Start date

2025-02-03

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

Supratentorial craniotomy Nalbuphine Tramadol Postoperative analgesia Supratentorial craniotomy Nalbuphine Tramadol Postoperative analgesia

Interventions

Nalbuphine via IV PCA,Tramadol via IV PCA

Experimental Drug,Active Comparator Drug

Nalbuphine,Tramadol

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Patients aged 18-65 years 2. Patients scheduled for craniotomy surgery 3. Preoperative risk level ASA classification 1-3 4. Able to be extubated in the operating room 5. Pre and post-operative Glasgow Coma Scale (GCS) score of 15 points

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. Communication disorders (Aphasia) before and/or after surgery 2. History of chronic opioid use 3. Cirrhosis 4. Chronic kidney disease stage greater than 3 5. History of allergy to study medications (Paracetamol, Dynastat, Nalbuphine, Tramadol, or Ondansetron) 6. Patients with respiratory depression 7. Acute asthma exacerbation or acute exacerbation of chronic obstructive pulmonary disease 8. History of substance abuse or chronic alcoholism 9. Patients who refuse or withdraw from the study

Design outcomes

Primary

Measure	Time frame
Postoperative pain score 6 hours Numberic rating scale(NRS)	—

Secondary

Measure	Time frame
Drug side effect 24 hours Nausea vomiting, sedation score ,Postoperative pain 24 hours Amount of analgesic drugs ,cumulative nalbuphine consumption at 24 h postoperatively at 24 hours after patient has arrived at recovery room quantitative measurement,cumulative tramadol consumption at 24 h postoperatively at 24 hours after patient has arrived at recovery room quantitative measurement,cumulative fentanyl consumption at 24 h postoperatively at 24 hours after patient has arrived at recovery room quantitative measurement	—

Measure

Time frame

Drug side effect 24 hours Nausea vomiting, sedation score ,Postoperative pain 24 hours Amount of analgesic drugs ,cumulative nalbuphine consumption at 24 h postoperatively at 24 hours after patient has arrived at recovery room quantitative measurement,cumulative tramadol consumption at 24 h postoperatively at 24 hours after patient has arrived at recovery room quantitative measurement,cumulative fentanyl consumption at 24 h postoperatively at 24 hours after patient has arrived at recovery room quantitative measurement

—

Countries

Thailand

Contacts

Public ContactJeeranut Wanawananon

Department of Anesthesiology Faculty of Medicine Ramathibodi Hospital, Mahidol University

Pukpuijar@hotmail.com0851300217

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026