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Analgesic Properties of Nefopam after Uvulopalatopharyngoplasty in patients with obstructive sleep apnea: A Randomized Controlled Trial

Analgesic Properties of Nefopam after Uvulopalatopharyngoplasty in patients with obstructive sleep apnea: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20210203007
Enrollment
52
Registered
2021-02-03
Start date
2021-10-01
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

Obstructive sleep apnea patients who undergo uvulopalatoplasty. uvulopalatoplasty obstructive sleep apnea pain nefopam

Interventions

20 mg of Nefopam solution (100ml) IV drip since the beginning of the operation until 24 hour,NSS solution (100 ml) IV drip since the beginning of the operation until 24 hour
Experimental Drug,Placebo Comparator Drug

Sponsors

Faculty of Medicine Siriraj Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Body mass index less than 40 kg/m2  Planned for uvulopalatoplasty Able to handle intravenous patient-controlled analgesia device  Understand Thai language Intend to participate

Exclusion criteria

Exclusion criteria: Contraindicated for nefopam i.e. epilepsy, glaucoma, currently on MAO inhibitor drugs or SSRI Contraindicated to parecoxib i.e. allergy to sulfonamide, ischemic heart disease, previous stroke Creatinine clearance less than 60 ml/min Cirrhosis; Child-Pugh class B or C Allergic to morphine, lidocaine, parecoxib, etericoxib, paracetamol, dexamethasone Chronic use of opioids or any drug abuse Chronic use or currently of any analgesic drugs

Design outcomes

Primary

MeasureTime frame
Morphine consumption 24 hour milligram of morphine used

Secondary

MeasureTime frame
Time to first analgesia within 24 hours minutes,pain score 30 min numeric rating scale,pain score 1 hour numeric rating scale,pain score 2 hour numeric rating scale,pain score 12 hour numeric rating scale,pain score 24 hour numeric rating scale,pain score 2 days numeric rating scale,pain score 3 days numeric rating scale,pain score 5 days numeric rating scale,pain score 7 days numeric rating scale,pain score 9 days numeric rating scale,pain score 14 days numeric rating scale,pain score 21 days numeric rating scale,Time to first drink within 24 hours hours,Time to first eat within 24 hours minutes,patient satisfaction 24 hour satisfaction score,patient satisfaction 7 days satisfaction score,patient satisfaction 14 days satisfaction score,Quality of life 24 hour EQ5D5L score,Quality of life 7 days EQ5D5L score,quality of life 14 days EQ5D5L score,Side effect : nausea and vomiting 24 hour severity score,Side effect : tachycardia 24 hours yes or no,side effect : drowsiness 24 hours severity score,side effect : urinary incontinence 24 hours yes or no,side effect : delirium 24 hour yes or no

Countries

Thailand

Contacts

Public ContactPeerachatra Mangmeesri

Department of Anesthesiology, Faculty of Medicine Siriraj Hospital

peerachatra@hotmail.com0629955659

Outcome results

None listed

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