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Comparative efficacy between paracetamol and paracetamol/tramadol in postoperative intertrochanteric fracture: A Noninferiority randomized control trial double-blind study

Comparative efficacy between paracetamol and paracetamol/tramadol in postoperative intertrochanteric fracture: A Noninferiority randomized control trial double-blind study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200201001
Enrollment
60
Registered
2020-02-01
Start date
2020-02-21
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

patients in Hadyai hospital who have intertrochanteric fracture intertrochanteric fracture hip fracture paracetamol tramadol

Interventions

tramadol 50 mg 1 capsule q8 hr with paracetamol 500 mg 1 tab q 6hr,paracetamol 500 mg 1 tab q 6hr with placebo 1 tab q 6hr
Active Comparator Drug,Placebo Comparator Drug
tramadol+paracetamol,Paracetamol

Sponsors

department of orthopedic hadyai hospital
Lead Sponsor
department of orthopedic hadyai hospital
Collaborator

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: The intertrochanteric fracture patients who were diagnosed by hip X-ray plain film assessing with anteroposterior (AP) view and lateral cross table, classified by AO/OTA classification (Figure 1), were eligible to enroll on the study. All patients were aged > 60 years, diagnosed with intertrochanteric fracture as aforementioned at either emergency room (ER) or out-patient department (OPD) service. Furthermore, all patients were required to understand the Thai language in terms of written and spoken abilities.

Exclusion criteria

Exclusion criteria: patients with multiple traumas, liver cirrhosis, disorientation, and a history of drug allergy to paracetamol, morphine, and tramadol were excluded from the study. According to the surgical procedures, the patients who were undergoing procedures other than cephalomedullary nail were also considered excluded from the study.

Design outcomes

Primary

MeasureTime frame
pain score admit date until discharge date Visual analog scale score

Secondary

MeasureTime frame
satisfaction score at discharge date likert's score

Countries

Thailand

Contacts

Public Contactsittha chuekitkumchorn

hadyai hospital

peachseaweed@gmail.com0846573808

Outcome results

None listed

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