Hashim, Ahmad
(2006)
A pilot study on procedural sedation among adult patients at Emergency Department HUSM, Kelantan comparing fentanyl with midazolam versus fentanyl with propofol.
Masters thesis, Universiti Sains Malaysia.
Abstract
Introduction
This is a pilot study looking at the safety and effectiveness of procedural sedation
technique carried out at the Emergency Department (ED) HUSM Kelantan over a
period of one year extending from December 2004 to December 2005. In other
words, there were no study has been carried out before to compare the
effectiveness and efficacy of using midazolam and propofol for any brief, intense
procedures in ED setting. With this study, the standard drugs used and the
measures during procedural sedation can be applied in all emergency departments.
Objectives
The objectives are:
1. to compare the safety and efficacy between a combination of fentanyl and
propofol with fentanyl and midazolam;
2. to obsetVe outcomes in subjects. undergoing a procedure at the ED when they
are under procedural sedation. These outcomes include the blood pressure,
mean arterial pressure, respiratory rate, heart rate, oxygen saturation, end tidal
carbon dioxide and duration to regain full consciousness after the procedural
sedation.
Methodology
Fourty patients were needed for its significant evaluation in this study. They were
randomly selected using the computer generated randotn permuted blocks of four
patients. 20 patients were grouped together as A and the remaining 20 patients as
group B. Drugs used were single blinded to prevent any biasness. Drug A
represents proporfol while drug B represents midazolam. The procedures involved
include, orthopaedic manipulation such as reduction of fractures, reduction of
dislocated joints, abcess drainage, toilet and wound debridment, laceration
wounds repaired and cardioversion.
These subjects were monitored for their vital signs and end tidal carbon dioxide
every ten minutes till the procedure is completed. The duration of recovery were
documented when the subjects had completed the procedure until regaining a full
consciousness or recovery. Patients were continued to be monitored at the
observation ward before being discharged home or admitted to the respective
ward. These findings were analysed using Mann-Whytney U statistical analysis.
Result
Majority of patients under study were represented by Malays and 75.6% were
males. The youngest subject was 13 years old while the oldest was 78 years of age
with the mean age of37.8 years.
None of the patients developed any complication while under procedural sedation.
Both propofol and mizadolam were found to be not significant (p value> 0.05) in
outcomes as follow:
1) Blood pressure
2) Mean Arterial pressure
3) Heart rate
4) Respiratory Rate
5) Oxygen saturation
6) End tidal C02
This study also found that patients who received propofol (mean 29 ± 11.03)
regained full consciousness at a much faster rate when compared to midazolam
(mean 71.75 ± 60.63), p value< 0.001, better choice of drug to be used in the ED
setting for procedural sedation.
The recommended dose for propofol to be used for procedural sedation at the ED
setting is lmglkg as a bolus dose followed by 0.5mglkg if required in a titrating
dose while for midazolam the recommended dose is 0.1 mg/kg as a bolus dose
followed by O.lmg/kg if needed in a titrating dose.
Capnograph has proven to be a very sensitive instrument to detect early sign of
hypoventilation and is strongly recommended to be used when procedural
sedation is performed at the ED setting.
Conclusion
This pilot study has proved there were no difference between the studied drugs
midazolam and propofol during procedural sedation. Instead, propofol has shown
to be more efficacious and shortened the recovery time for patients to regain full
consciousness.
These two drugs can be used as procedura1 sedation agents in ED for various short
intense painfu] procedures.
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