UWCScholar :: Browsing by Author "Roelofse, James"

Browsing by Author "Roelofse, James"

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A comparison of the efficacy and safety of intranasal sufentanil/midazolam and ketamine/midazolam for sedation and analgesia in a paediatric population undergoing multiple dental extractions
(2005) De La Harpe, Charl Jacques; Roelofse, James
This study was designed to evaluate the efficacy and safety of intranasal sufentanil/midazolam [S/M] and ketamine/madazolam [K/M] for sedation and analgesia in preschool children that require dental surgery [extractions]. Fifty children [ASA 1] aged 5 – 7 years, requiring six or more dental extractions under general anaesthesia, were allocated to two groups of 25 children to receive either ketamine 5 mg/kg or sufentanil 20μg intranasally, 20 minutes before induction of surgery in this randomised double-blind study. All the children in both groups in addition concurrently received nasal midazolam 0,3 mg/kg. For induction of anaesthesia, sevoflurane in nitrous oxide and oxygen, was used. S/M was accepted significantly better as a nasal pre-medication [p<0.05]. Both groups were equally sedated and a smooth mask induction of anaesthesia was experienced in the majority of children. Recovery of children in both groups were similar; 82% of the S/M group were fully recovered 120 minutes post-operatively versus 80% in the K/M group [p>0,05]. Effective postoperative analgesia for multiple extractions was provided. For pain evaluation, children were divided into two groups, a non-responder group where all pain values over time were more than 40 and a responder group where pain values were equal to, or less than 40. Seventy two percent of children in the S/M group were responders as to fifty two percent in the K/M group [p>0,05]. No adverse respiratory, cardiovascular or other effects were recorded. This study showed that intranasal administration of sufentanil /midazolam or ketamine/midazolam, provides safe and effective sedation and analgesia in children aged 5–7 years undergoing multiple dental extractions.
The comparison of two doses of intranasal midazolam sedation in a paediatric dental emergency clinic
(University of Western Cape, 2011) Mahgoub, Ahmed Elsheikh Omer; Peerbhay, Fathima; Roelofse, James
The aim of the study was to compare two doses of intranasal midazolam (INM) 0.3 mg/kg and 0.5 mg/kg in terms of effectiveness and recovery time. Design:-This study was a Randomized Controlled Trial (RCT) and Triple blinded study. Sample and methods A sample of one hundred and eighteen children aged from 4-6 years old were randomly assigned for Intranasal sedation (INS) to either the 0.3 mg/kg group or the 0.5 mg/kg group. Children were taken in fasting and non-fasting conditions. The children were monitored using a pulse-oximeter, the sedation was assessed using Wilson sedation scale and the anxiety and behaviour scales were rated by Venham’s scale throughout the treatment. The facial image Scale (FIS) was also used to assess anxiety and mood of children before and after treatment. Results The mean BMI of children was found to be from 14-16. Intranasal sedation with both 0.3 mg/kg and 0.5 mg/kg midazolam was completed in 100% of the children. The pulse rates were within normal limit but statistically lower in the 0.5 mg/kg group. Oxygen saturation was above 98% in all except for one child who desaturated to 90%. Thirty five percent found this route acceptable in this study; Nine percent had burning sensation from midazolam. The state anxiety between the two groups of 0.3 mg/kg and 0.5 mg/kg were insignificant using Venham’s scale. However, behaviour scores showed statistical significant results of p value (0.03) and (0.04) in the behaviour during LA and behaviour during extractions respectively. The facial images scale (FIS) ratings chosen by the children before and after sedation was insignificant to the anxiety and behaviour ratings. The FIS revealed that 66% chose a happy face at the end of treatment. Fifty percent of the children in the study chose the same image before and after sedation. There were no adverse events encountered during the procedure. Conclusion INS with midazolam using the 0.3 mg/kg or 0.5 mg/kg doses resulted in safe and effective sedation. The 0.5 mg/kg proved to be more effective than the 0.3 mg/kg in providing better behaviour and decreasing anxiety when compared with the 0.3 mg/kg dose. The 0.5 mg/kg dose was found to be safe and the recovery time was slightly more than the 0.3 mg/kg but the difference was not clinically significant.
The efficacy and safety of intravenous sedation in children under the age of 10 years
(University of the Western Cape, 2013) Swart, Ellison Margaret; Roelofse, James
This study was done to show that sedation is a safe and a viable option in young children. Dental procedures were done on children aged two to ten years. Two hundred children were included in the study. In all of these children the procedures were completed. Only two children were excluded, because an intravenous line could not be placed on the one child, and the other child was unmanageable under sedation. The safety of sedation was evaluated looking at the incidence of adverse events and complications. No serious adverse effects or complications occurred. The complications that occurred were all corrected with minimal or non-invasive interventions. Only six of the two hundred children required oxygen to correct a drop in oxygen saturation.
Fast track assessment of the conscious sedation patient at the pre treatment consultation in a dental day clinic
(University of Westen Cape, 2005) Nagtegaal, Hendrik; Roelofse, James
This thesis covered the fast track assessment of the referred dental patient for conscious sedation in a day clinic. The assessment took in consideration patient information, medical history, anatomical observations, treatment required, phobic aspects and patient expectations.
The management of a safe and cost effective conscious sedation unit
(University of the Western Cape, 2016) Carstens, Hendrik Andries; Roelofse, James
Conscious sedation or moderate sedation and analgesia is an effective and popular alternative option for procedures outside the operating theater. If conscious sedation is a viable alternative to general anaesthesia then we as sedation practitioners must use safe sedation techniques in facilities that meet all the requirements for safe practice. Three studies were done to determine the safety and efficacy of conscious sedation outside the operating theatre. In the first study post sedation satisfaction in one hundred children aged 3-9 years was evaluated. It was extremely important to determine whether the combination of midazolam, ketamine and propofol, called an advanced sedation technique (SASA, 2015), can be safely used for paediatric sedation outside the operating theatre. The incidence of side-effects after conscious sedation using multiple drugs were documented. It is clear that intravenous sedation with midazolam, ketamine and propofol is safe and effective to use. There may be side effects but they are not long lasting and usually not life-threatening. In the second study intravenous sedation was administered to 447 adults (aged 18 years and older) using fentanyl (sublimazeR), ketamine (ketalar), midazolam (dormicum) and propofol (Diprivan) (FKMP) called an advanced sedation technique. Post sedation satisfaction, post sedation recovery on arrival home, and the relationship between side effects and different dental procedures were evaluated. The results of the study show that side effects are possible, and can be expected, when we use sedative and analgesic drugs for sedation. However, we report a low incidence of side effects when we compare it with other studies in literature as mentioned. It is known that the use of combinations of drugs may cause unforeseen synergistic pharmacological effects which can be lifethreatening. Our results show that the drugs used can be safely used for advanced sedation techniques. In trying to demonstrate the safety of sedative and analgesic agents used during sedation we looked at the haemodynamic parameters, duration of sedation, pulse rate and systolic blood pressure, in the third study. The sedation records of 335 patients for dental surgery were assessed for the period 2010 – 2011. Our results show the mean Duration of sedation is substantially and statistically significantly greater with combination FKMP than with the other combinations. The mean duration of sedation is not significantly different between ketamine and propofol (KP) and fentanyl, ketamine and propofol (FKP) (Figure 10). The use of polypharmacy regarding the combination of drugs, specifically FKMP, will cause a longer duration of sedation. This has implications for safety, as well as the side effect profile during and after sedation. When we use combinations of drugs patients were more comfortable which shows that we do not yet have a single drug that has all the characteristics of an ideal drug for sedation. Different combinations of drugs are used by other practitioners with a higher incidence of side effects. It is difficult to explain the higher values of blood pressures when all four drugs were used. It may have been a ketamine effect, although one would not expect this when using propofol with ketamine. In clinical terms the higher blood pressures are no reason for concern as all our patients were classified as ASA I and II. Our research study support the view that ketamine can be used safely outside the operating theatre with exciting possibilities for Third World countries for procedures outside the operating theatre. Sedation can be considered a reasonable alternative to general anaesthesia for certain surgical procedures in the Third World. Sedation will be an attractive option not only as far as costs are involved but also the availability of sedation providers. The important lesson from all the results is that sedation providers must be trained in procedural sedation as defined by all international sedation guidelines. We proved in this research study that sedation can be done safely, however we need to make a contribution to train sedation providers. Sedation will become an attractive alternative to general anaesthesia because of the low side-effect profile and high patient satisfaction. It is interesting that few studies are available that looked at this aspect of sedation. It is clear that a high side-effect profile can contribute to an unsafe sedation technique. Severe nausea and vomiting can cause numerous haemodynamic disturbances and dehydration. Our research study support the findings of the study by Lapere et al., (2015) that there is a high rate of patient satisfaction, and a low side-effect profile during and after sedation. This is an extremely important research study and the results are crucial as far as an option for healthcare in developing countries. Sub-Saharan Africa is a densely populated and resource poor subcontinent that provides unique challenges in patient care. These challenges include a lack of facilities and staff for the performance of operative as well as non-operative procedures. In conclusion, we feel that we are part of Sub-Saharan Africa with all the problems mentioned as far as provision of healthcare is concerned. This research study can make a crucial contribution to safe and cost-effective management of healthcare in Africa for procedures outside the operating theatre.
Multidrug sedation for dental procedures in children younger than eight
(University of the Western Cape, 2005) Bester, E.J.; Roelofse, James; Faculty of Dentistry
In this case study research project I have determined that multidrug sedation in children younger than eight years are possible.Conscious sedation [or sedation where verbal contact with the patient is possible] can be used successfully to decrease anxiety and fear for unpleasant experiences, like dental procedures. Behaviour therapy in conjunction with one or more drugs can be used to depress the central nervous system in order to decrease the patient’s awareness of unpleasant stimuli. This enables treatment to be carried out without patient interference. Extensive literature surveys were done to determine the ideal drugs as well as the ideal route for conscious sedation in dental treatment for children. In this study project drugs like midazolam, propofol, alfentanyl and ketamine were titrated intravenously to achieve conscious sedation.
Procedural sedation competencies: a review and multidisciplinary international consensus statement on knowledge, skills, training, and credentialing
(Elsevier Ltd, 2025) Roelofse, James; Leroy, Piet L.; Krauss, Baruch S.; Krauss, Baruch S.
Procedural sedation is practised by a heterogeneous group of practitioners working in a wide array of settings. However, there are currently no accepted standards for the competencies a sedation practitioner should have, the content of sedation training programmes, and guidelines for credentialing. The multidisciplinary International Committee for the Advancement of Procedural Sedation sought to develop a consensus statement on the following: which competencies should medical or dental practitioners have for procedural sedation and how are they obtained, assessed, maintained, and privileged. Using the framework of Competency-Based Medical Education, the practice of procedural sedation was defined as a complex professional task requiring demonstrable integration of different competencies. For each question, the results of a literature review were synthetised into preliminary statements. Following an iterative Delphi review method, final consensus was reached. Using multispeciality consensus, we defined procedural sedation competence by identifying a set of core competencies in the domains of knowledge, skills, and attitudes across physical safety, effectiveness, psychological safety, and deliberate practice. In addition, we present a standardised framework for competency-based training and credentialing of procedural sedation practitioners. © 2024 The Author(s)
The safety and efficacy of the propofol/ Alfentanil/ Ketamine-bolus technique in midazolam pre-medicated patients undergoing office based plastic or reconstructive surgery
(University of the Western Cape, 2007) Venter, J. C.; Roelofse, James; Faculty of Dentistry
The purpose of this research project was to assess the safety and efficacy of a combination of drugs for conscious sedation in patients undergoing office-based plastic and reconstructive surgery. A pilot study was done to determine the safety of the co-administration of the drugs used in the sedation technique.
Sedating children in South Africa
(Taylor & Francis, 2017) Gray, Rebecca; Roelofse, James
Regarding 'Sedation for paediatric auditory electrophysiology in South Africa' we thank the authors for publishing their research thereby giving us documentary proof of what we know to be widespread practice. Sedation has, for many years, been poorly documented and not subject to the standards in respect of monitoring, medications administered, staff ratios and clinical governance that is its due. Several closed claims analyses and numerous reviews have recognised that paediatric sedation, in particular, is associated with an increased morbidity and mortality. As the authors indicate, there is increasing pressure from practitioners, funders and patients or parents for procedures to take place outside the operating room; the age limit at which this is deemed acceptable is being pushed lower and lower. In addition, the complexity and length of these procedures is increasing.

Browsing by Author "Roelofse, James"

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