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Nefopam-Pentazocine Equivalence Trial

A Randomised Controlled Equivalence Trial Comparing Nefopam and Pentazocine for Postoperative Pain Management after Major Gynaecological Surgery in Ibadan, Nigeria

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202607619431646
Enrollment
176
Registered
2026-07-07
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Post major gynaecogical surgery pain management

Interventions

PENTAZOCINE DICLOFENAC
NEFOPAM DICLOFENAC

Sponsors

Bankole ADEWUMI
Lead Sponsor
Merit Healthcare Ltd
Collaborator
Biocodex
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: This will include women scheduled for major gynaecology surgery who are • 18 years of age or above • Scheduled for elective major gynaecological surgery. • American Society of Anesthesiologists (ASA) Physical Status I–III. • Able to understand and communicate using the DVPRS • Patients with normal renal and liver function test

Exclusion criteria

Exclusion criteria: This will include participants scheduled for major gynaecology surgery who are • With history of prolonged use of opioid analgesics e.g. sickle cell patients, patients with neuropathy etc • Diagnosed or being managed for cancers or malignancies • Known allergy or hypersensitivity to nefopam, pentazocine or diclofenac. • With deranged liver or kidney function test or coagulopathy • History of seizure disorder of severe psychiatric illness • Currently pregnant. • Visually impaired

Design outcomes

Primary

MeasureTime frame
The average postoperative pain score during the first 24 hours following surgery measured using the Defense and Veterans Pain Rating Scale (DVPRS).

Secondary

MeasureTime frame
The incidence of adverse drug reaction observed for either of the study group;The effects of either of the study drugs on the patients’ haemodynamical parameter inclusive of Blood pressure, Pulse Rate, Respiratory Rate and Oxygen saturation;The requirement for rescue analgesia in either group - time to first rescue analgesia and number of times rescue analgesia given;The overall level of satisfaction of the post-operative pain management

Countries

Nigeria

Contacts

Public ContactBankole ADEWUMI

Senior Resident Doctor at Department of Obstetrics and Gynaecology University College Hospital

bankole.adewumi@uch-ibadan.org.ng+2348033967253

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026