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Comparing Nalbuphine versus Tramadol to prevent Shivering after Lower limb surgery

COMPARISON OF THE EFFECTIVENESS OF NALBUPHINE VERSUS TRAMADOL FOR PREVENTION OF POST SPINAL SHIVERING IN PATIENTS UNDERGOING LOWER LIMB SURGERY AT TERTIARY CARE HOSPITAL, KARACHI

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241106063628N1
Enrollment
60
Registered
2024-11-15
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Shivering. Chills (without fever)

Interventions

Intervention 1: Intervention group: Nalbuphine Group (NG)- Description: Patients receiving nalbuphine (0.5 mg/kg) intravenously over 5 minutes. Intervention 2: Intervention group: Tramadol Group (TG)-

Sponsors

National Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients of either sex, between 20-60 years of age, receiving spinal anesthesia during lower limb surgery will be included in the study. ASA = 2

Exclusion criteria

Exclusion criteria: Patients undergoing emergency surgeries, deformities of the spine, hypersensitivity to any of the drugs in the study. Patients with thyroid or neuromuscular diseases. Patients on narcotics/sedatives. Patients allergic to nalbuphine or tramadol. Patients with an initial body (core) temperature >38.0°C or <36.0°C. Patients with h/o stroke, renal impairment, chronic obstructive pulmonary disease, asthma, chronic liver disease, and CCF will be excluded.

Design outcomes

Primary

MeasureTime frame
Shivering Assessment. Timepoint: initially at baseline (before intervention): immediately before administration Nalbuphine or Tramadol then, (post intervention): 15 minutes then 30 minutes, 1 hour then post surgery: 2hours. Method of measurement: Shivering assessment via grades 0 to 4:Grade 0: No shivering.•Grade 1: One or more of the following: Piloerection, peripheral vasoconstriction, peripheral cyanosis with, but without visible muscle activity.•Grade 2: Visible muscle activity confined to one muscle group.•Grade 3: Visible muscle activity in more than one muscle group.•Grade 4: Gross muscle activity involving the whole body.

Secondary

MeasureTime frame
Shivering Assessment. Timepoint: initially at baseline (before intervention): immediately before administration Nalbuphine or Tramadol then, (post intervention): 15 minutes then 30 minutes, 1 hour then post surgery: 2hours. Method of measurement: shivering assessment via grades 0 to 4: Grade 0: No shivering.• Grade 1: One or more of the following: Piloerection, peripheral vasoconstriction, peripheral cyanosis with, but without visible muscle activity.• Grade 2: Visible muscle activity confined to one muscle group.• Grade 3: Visible muscle activity in more than one muscle group.• Grade 4: Gross muscle activity involving the whole body.

Countries

Pakistan

Contacts

Public ContactProf.Brig.(R).Aneel Aslam

National Medical Center

Akashdosani007@gmail.com+92 330 8431329

Outcome results

None listed

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