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The Effectiveness of Perioperative Parecoxib Intravenous Administration in the Surgical Fixation of Unstable Ankle Fracture: A Prospective, Double-Blinded, Randomized, Placebo-Controlled Trial.

The Effectiveness of Perioperative Parecoxib Intravenous Administration in the Surgical Fixation of Unstable Ankle Fracture: A Prospective, Double-Blinded, Randomized, Placebo-Controlled Trial.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210416003
Enrollment
44
Registered
2021-04-16
Start date
2018-07-03
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

The patients with unstable ankle fractures who have surgical indications. Analgesia Ankle fractures parecoxib perioperative randomised controlled trial

Interventions

Group A, parecoxib 40 mg IV 30 min before surgery and then additional 40 mg every 12 hours for 48 hours after surgery , Group B, placebo or normal saline 10 ml, IV 30 min before surgery and then addit
Active Comparator Drug,Placebo Comparator Drug
Perioperative Parecoxib, intravenous injections,Normal saline, intravenous injection

Sponsors

American Orthopaedic Foot & Ankle Society
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: The patient with unstable ankle fracture who had the indication for open reduction and internal fixation.

Exclusion criteria

Exclusion criteria: The contraindication of parecoxib use (1 pateint), thrombocytopenia on preoperative blood work (1 patient), head injury with contraindication for spinal anesthesia (1 patient), and acute on chronic fracture (1 patient).

Design outcomes

Primary

MeasureTime frame
Pain and related scores, amount of morphine used Time 0 was recorded when the patients were move to the post-anesthesia care unit (PACU) after surgery. The VNRS and VNRP were recorded at 0, 4, 12, 24 and 48 hours after surgery by trained personnel. verbal numerical rating score, verbal numerical rating percentage, patient subjective rating of the medication, amount of intravenous morphine administered, overall adverse effects

Secondary

MeasureTime frame
N/A N/A N/A

Countries

Thailand

Contacts

Public ContactChayanin Angthong

Thammasat University

chatthara@yahoo.com023298029

Outcome results

None listed

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