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Propofol is a commonly used intravenous anesthetic agent, but its administration is frequently associated with injection pain, causing patient discomfort and agitation. Various pharmacological agents have been used to reduce this pain, including nalbuphine and lidocaine; however, results from previous studies remain conflicting. This randomized clinical trial aims to compare the effectiveness of intravenous nalbuphine versus intravenous lidocaine in reducing the frequency of propofol-induced injection pain in patients undergoing elective general surgery procedures.
Propofol-induced injection pain is a common and undesirable adverse effect that can lead to patient distress during induction of anesthesia. Nalbuphine, a kappa-opioid receptor agonist and partial mu-opioid receptor antagonist, and lidocaine, a sodium channel blocker, have both been used to reduce this pain, but evidence regarding their comparative effectiveness remains inconsistent.
This randomized clinical trial will be conducted in the Department of Anesthesiology, PGMI / Hayatabad Medical Complex, Peshawar. A total of 92 adult patients with ASA physical status I-II, scheduled for elective general surgery under general anesthesia, will be enrolled and randomized into two equal groups. Group A will receive intravenous nalbuphine at a dose of 0.1 mg/kg, while Group B will receive intravenous lidocaine at a dose of 4.5 mg/kg (maximum 300 mg), administered 60 seconds prior to induction with propofol. Injection pain will be assessed by the inducing anesthesiologist using a four-point pai
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nalbupine group | Experimental | Patient recieving intravenous nalbuphine prior to propofol induction |
|
| Lidocaine group | Active Comparator | Patient recieving intravenous lidocaine prior to propofol induction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalbuphine | Drug | Intravenous nalbuphine 0.1mg/kg administred 60second prior to induction with propofol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of propofol- induced injection pain | Presence of injection pain assessed using a four-point pain scale during propofol injection until loss of eyelash reflex. Pain score ≥1 will be considered as presence of injection pain. | During induction of anesthesia (within 1-2 minutes of propofol administration |
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Inclusion Criteria:
Age 18-60 years
Exclusion Criteria:
Known hypersensitivity to propofol, nalbuphine, or lidocaine
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr.Arina kore Trainee medical officer, MBBS | Contact | +923446835431 | Kore2k15@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr.Arina kore Trainee medical officer, MBBS | PGMI/Hayatabad Medical complex(HMC),Peshawar | Principal Investigator |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
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Individual participant data will not be shared due to patient confidentiality and instituional policies
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009266 | Nalbuphine |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Lidocaine | Drug | Intravenous lidocaine 4.5mg/kg (maximum 300mg) administred 60sec prior to induction with propofol |
|
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |