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Hyoscine N-butylbromide for preventing propofol injection pain

Hyoscine N-butylbromide for preventing propofol injection pain: A randomized, placebo-controlled, double-blind study in patients undergoing routine outpatient surgery under general anesthesia

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000142437
Enrollment
60
Registered
2016-02-05
Start date
2016-02-22
Completion date
2017-01-02
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Sixty patients between the ages of 18-65 yr, ASA physical status I and II, scheduled to undergo routine outpatient surgery under general anesthesia, were studied. Exclusion criteria included allergy to the study drugs, end-stage renal disease, pregnancy, patients taking sedatives or analgesics, patients requiring a rapid sequence induction and intubation, refusal to participate, and patients with a neurological or cardiovascular disease. The patients were randomized, by using a computer-generated block randomisation, into 2 groups: Group C (n=30) 0.9 % sodium chloride, Group H (n=30) Hyoscine N-butylbromide 20 mg. Both placebo (0.9 % sodium chloride) and Hyoscine N-butylbromide were prepared in identical syringes by an anesthesia nurse who were blind to study. For each patient, study team personnel received a syringe and a data collection sheet, both labeled with the study subject number. In all patients, a 20-gauge intravenous cannula was inserted in the radial vein at the wrist of the right hand for intravenous (IV) fluids and medication administration. After applying routine monitors (consisting of a pulse oximeter, 3-lead ECG and a non-invasive blood pressure cuff ) and providing pre-oxygenation in the operating room, the assigned study drug was injected by bolus over 2–3 seconds. The intravenous line containing lactated ringers solution was then allowed to flow freely. After twenty seconds, a 50-mg dose of propofol at room temperature was injected by bolus over 2–3 seconds, followed again by free flow of the lactated ringers solution. Ten seconds following the injection of propofol, each patient was asked a standard question about pain on injection (‘‘Are you having pain at your IV site?’’) and their responses were noted by an anesthesiologist, who was blinded to study. Injection pain severity was assessed using the following four-point pain response scale: 0 = no pain; 1 = mild pain (pain reported only in response to questioning and without behavioral signs); 2 = moderate pain (pain reported in response to questioning and accompanied by a behavioral sign, or pain reported spontaneously without questioning); and 3 = severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal, or tears).

Interventions

Drug administration (Hyoscine N-butylbromide) 20 mg intravenously (a single dose) just before propofol injection

Sponsors

Konya Training and Research Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

ASA physical status I and II, scheduled to undergo routine outpatient surgery under general anesthesia

Exclusion criteria

An allergy to the study drugs, end-stage renal disease, pregnancy, patients taking sedatives or analgesics, patients requiring a rapid sequence induction and intubation, refusal to participate, and patients with a neurological or cardiovascular disease.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026