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Analgesic Efficacy and Safety of IV Nalbuphine Versus IV Butorphanol in patients undergoing Tympanoplasty

A Prospective Randomized comparative study about clinical evaluation of analgesic efficacy and safety of IV Nalbuphine Vs IV Butorphanol in patients undergoing tympanoplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027482
Enrollment
120
Registered
2020-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: H729- Unspecified perforation of tympanic membrane

Interventions

Intervention1: inj. nalbuphine: opioid analgesic 0.2 mg/kg, intravenous, single dose Control Intervention1: inj. butirphanol : opioid analgesic 0.02mg/kg, intravenously, single dose

Sponsors

Dr Shruti Hazari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients giving consent Patients undergoing elective Tympanoplasty surgery Patients under ASA 1 and ASA2

Exclusion criteria

Exclusion criteria: Patient refusal Patients ASA 3 or more Patients on opioid or sedatives Alcohol intake Hypersensitivity reaction

Design outcomes

Primary

MeasureTime frame
Analgesic properties, response to pin prickTimepoint: baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, duration noted when patient complains of emergence of pain

Secondary

MeasureTime frame
Vas score, Ramsay sedation score, heart rate, blood pressure, saturation, side effects, intraoperative use of rescue analgesia, duration of actionTimepoint: Over 3-5 hours

Countries

India

Contacts

Public ContactDr Shruti Hazari

Dr. D. Y. Patil school of medicine

varsha.vyas011@gmail.com9819583232

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026