Pediatric Sedation in the Underdeveloped Third World: An African Perspective—Models, Protocols, and Challenges



Brief: <10 min

Intermediate: 10–20 min

Extended: >20 min

Adapted from Green SM, Roback MG, Miner JR, Burton JH, Krauss B. Fasting and Emergency Department Procedural Sedation and Analgesia: A Consensus-Based Clinical Practice Advisory. Ann Emerg Med. 2007; 49(4): 454–461




Table 25.2
Patients with potentially difficult airways



































Obstructive sleep apnea (OSA)

Large tonsils approaching the midline, or associated with loud snoring

Children who cannot lie flat because of airway obstruction

Stridor

Retropharyngeal masses

Neck masses

Tracheal deviation

Mallampati class 3 or 4

Neck mobility: decreased range of movement, including hydrocephalus with a large head

Syndromic features (e.g., Pierre-Robin, Treacher-Collins):

• Enlarged tongue

• Micrognathia

• Abnormal ears

Hemangiomas

Beware of children with malignancies: multiple level airway obstruction is possible


Reprinted with permission from Reed A, Thomas J, Roelofse JA, Gray R, de Kock M, Piercy J. Paediatric Procedural Sedation and Analgesia (PSA) Guidelines; South African Society of Anaesthesiologists. 2011


Written informed consent must be obtained and verbal and written instructions for, before and after the sedation procedure must be conveyed to a responsible person.



Provision of Sedation


Facilities must comply with the standards required for safe pediatric sedation outside the operating room. Attention should be focused on the procedure room where the appropriate staff, drugs, and equipment must be available to monitor and rescue a child.

Equipment for pediatric sedation should be appropriate for the intended procedure as well as the targeted depth of sedation. Monitoring equipment for all but the simple single agent (oral or inhalation) technique should include electrocardiogram (ECG), blood pressure, and pulse oximetry. If available, an end-tidal carbon dioxide monitor should be used. The precordial stethoscope remains an inexpensive and practical monitor, especially in under-resourced rural settings. The availability of a defibrillator is desirable wherever pediatric sedation performed, especially when combined drug techniques are employed [15]. (Refer to Chap. 3.)

Documentation and protocols must comply with contemporary guidance [7, 9, 16]. This includes documentation before, during, and after sedation. All parameters that are monitored during sedation must be documented and any adverse events entered on a sedation chart.


Recovery and Discharge


Recovery facilities must meet all the requirements for safe recovery of the child after sedation. No child should be sedated without an escort being available to accompany the child home. A protocol for back-up emergency services must be available for all cases done outside the operating room and ready access to ambulance services is advised wherever pediatric sedation is performed.



Guidelines for Mobile Sedation Practitioners


Safe practice of mobile sedation requires that the sedation practitioner takes responsibility for all the requirements of safe sedation practice. These include the suitability of the premises, the pre-sedation assessment, intraoperative care, documentation, and postoperative discharge of the child. A not unreasonable assumption is that the premises will provide only suction and light. The sedation practitioner must provide all the drugs, disposables, equipment (including resuscitation equipment) that may be needed. The sedation practitioner is also responsible for ensuring that suitably qualified health care professionals are available to assist with monitoring and rescue, if needed.

Routine equipment requirements should include: a stethoscope (preferably also a precordial stethoscope), blood pressure monitor, glucometer, and pulse oximeter. Mobile sedation practitioners are encouraged to use an ECG monitor and capnography, particularly when pediatric advanced sedation techniques are performed, or when deep sedation is intended. They are advised to carry a spare pulse oximeter. A thermometer is also advisable, especially as children often present with a runny nose and other respiratory symptoms for which an infectious process must be ruled out. It is also advisable to carry a glucometer. The mobile kit should also include items that improve patient comfort and safety, i.e., a blanket to keep the child warm, a cushion to put behind the shoulders to extend the neck, butterfly sponges to protect the airway from water in pediatric dental cases, and a radio with earphones to play music for the older child.

The kit should also contain emergency equipment such as oxygen, nasal cannulae, a self-inflating resuscitator, airways (nasal and oral), pediatric laryngoscope and blades, a suction catheter, endotracheal tubes, laryngeal mask airways, Magill’s forceps, resuscitation drugs, and a defibrillator [15]. Mobile sedation practitioners usually operate in the private health care environment where the patients are responsible for the expenses and most carry medical insurance.

A mobile sedation practitioner must also have access to appropriate office infrastructure. This includes secretarial services to take care of appointments, the preparation of paperwork that should be sent to the parents ahead of time in respect of preoperative and postoperative instructions, and to gather information regarding the health status of the child. A patient follow-up system should be in place to allow the guardian to give postoperative feedback. The questionnaire allows for feedback on patient satisfaction and possible side effects, such as postoperative nausea and vomiting, pain during the procedure, double vision, and emotional disturbances. The form should also invite comment as to whether the parent and child would prefer sedation again; or rather opt for general anesthesia.


Behavioral Management of the Child


The single most important aspect of any successful sedation is to gain the child’s trust. Earning a child’s trust is not always easy, particularly if there have been past traumatic experiences with general anesthesia or sedation. All sedation techniques must include planning behavioral management strategies, empathy, understanding, and a patient approach. (Refer to Chap. 34.) The protocol for successful behavior management must incorporate two strategies: how to “read the mind” of the child [18] and how to use the specific practical guidelines. When trying to “read the mind” of the child, it is vital to try and establish a good personal relationship in order to gain their trust. This means placing yourself in the child’s shoes and establishing rapport. Five important points to remember when interacting with a child are: (1) imagine you are the same age as the child you are dealing with, (2) use words that a child can understand, (3) do not lie to the child (this does not mean that one needs to disclose all details), (4) offer encouragement by telling him/her that he/she is good and brave to ensure that the child feels proud, and (4) use the information you get from the child to play mind games [18]. Always speak to children slowly and gently and talk to them about pleasant things, i.e., the smell of their favorite food, the ocean, paintings, etc. A child who does not want to make eye contact is not interested in what you are saying and will ignore attempts to establish rapport. Such children are difficult to sedate and may need a different approach and deeper levels of sedation.

The following practical hints may be useful for sedation practitioners and the team to establish a rapport with a child:



  • The office/surgery, where procedures are to be performed, is a threatening environment for most children. Communication should not take place in the operating room but in a friendlier environment where the child can be made comfortable. He/she should be encouraged to ask questions and his/her consent should be obtained for the proposed sedation where possible.


  • Wear casual, non-operating room clothing—appearing too formal may create anxiety in children, especially if they had previous negative experiences during general anesthesia.


  • What you say is less important than how you say it. The attitude of the sedation practitioner is an important determinant of success. It is essential that the sedation practitioner shows confidence in what he or she is doing. The child and parent must be confident that the sedation provider knows exactly what is to be done, has the necessary experience, and can deliver safely on the promises. One should never afford the child or parent the opportunity to doubt one’s professional ability. Always have a positive attitude that, at times, may be quite difficult. Show the child that you are enthusiastic about what you do and that you are excited to be in a position to be able to help. Confidence in one’s own success as a sedation practitioner may convince the child that, even though his anxiety is valid, together the two of you can be successful. Never direct your conversation at the parent or escort; always involve the child irrespective of age. Always establish and maintain eye contact with the child—this simple gesture shows the child that you really care.


  • Try to find an “ice-breaker” (a means of eliciting the child’s trust and allaying his anxiety and fear) when first meeting the child by making a friendly non-threatening statement to start the conversation—this may be all that is needed to settle the child down. It is always good to find out about the interests of the child.


  • Never look down at the child—if the child is seated or lying down, sit down beside him. It may even be advisable to sit on your haunches in front of the child. That way, your eyes are at the same level and it makes it much easier for the child to relate to the sedation practitioner.


  • It is crucial that children never to be crowded—they need their personal space to feel respected.


  • It is always wise to tell the child that you need his or her help and that sedation means a team effort.

Children are very susceptible to suggestion. Something like, “I cannot do this without your help” will go a long way toward making the child comfortable. In case of an intravenous cannulation, tell the child that a butterfly will come and sit on his/her hand. You are allowed to choose the color of the butterfly.

A final question: Do cultural factors play a role in the outcome, success rate, and/or achievability of multidrug sedation in children over the age of 5 years? A study of 354 children from eight different cultural groups showed that cultural factors do not influence the outcome, success, or achievability of multidrug sedation in children. The study, however, validated the importance of preoperative selection and assessment and the use of behavior management techniques [19].


Common Sedation Strategies in the Developing Nations



Oral Route: Single Agent


It is not routine practice to administer oral sedatives for surgical procedures. Children’s behavior patterns vary and it is essential to do a behavioral assessment prior to the procedure. It is good practice to discuss this with the parent or guardian before sedation, as they usually can give the sedation practitioner guidance as to whether the child needs an oral sedative before surgery. Some children are, however, just too frightened due to previous traumatic experiences, and may thus need a sedative. An oral sedative must never be given to the child at home but in the facility where the procedure will be done.

Chloral hydrate is a sedative hypnotic still being used in some hospitals for sedation for children under the age of 3 years, especially for painless imaging [20]. The drug has no analgesic activities and the usual dose is 20–75 mg/kg, given orally.

Midazolam is a short-acting, water-soluble benzodiazepine with no analgesic properties. It is the most commonly used benzodiazepine for pediatric sedation and can be administered via various routes. The oral dose is 0.35 mg/kg, 20–30 min before surgery [21]. To make it easier to remember, we advise sedation providers to administer 7.5 mg orally to those children above 8 years of age, and 5 mg to those less than 8 years of age. The child must be constantly supervised and monitored after administration of the oral sedative. Midazolam is not available in a syrup formulation in Africa, so instead the tablet is crushed and diluted with paracetamol syrup. Alternatively, the aqueous formulation for intravenous midazolam is administered orally. Midazolam is a useful sedative in combination with other oral drugs.

Oral ketamine provides excellent sedation, analgesia, and amnesia and can also be used for painful procedures. In the developing world, it is usually combined with midazolam. Oral ketamine is useful for burn debridement in children at a dose of 10 mg/kg because of its excellent safety profile [22]. Acceptable sedation for dental procedures was achieved in children, 2–7 years of age, by the use of 12.5 mg/kg oral ketamine. The incidence of hallucinations was 16.6 % [23].

Ketamine administered orally is used extensively for analgesia and sedation during dressing changes in children suffering from burn injuries at the Red Cross War Memorial Children’s hospital in South Africa [24]. A recent study from this institution in children between 1 and 8 years of age suggests that oral ketamine 5–10 mg/kg via a nasogastric tube with intravenous supplementation of 0.5–1 mg/kg provides reasonable sedation and analgesia for short dressing changes. Furthermore, oral ketamine administration results in high norketamine concentrations due to first-pass metabolism in turn contributing to good long-lasting post-procedural analgesia. Oral ketamine may serve as a valuable premedicant, sedative, and analgesic for children suffering from burn injuries.


Nasal Route: Single Agent


Intranasal midazolam may be uncomfortable for children as it may cause a burning sensation. It is, however, useful in children who refuse to take medication by mouth, are vomiting, or are developmentally delayed. Although a tuberculin syringe can be used to administer 0.2 mg/kg midazolam intranasally, a Mucosal Atomization Device (MAD®, LMA North America, San Diego, CA) is available and makes nasal administration easier and more acceptable.


Rectal Route: Single Agent


Rectal administration of midazolam is useful for providing sedation for younger children (Table 25.3). Acceptance is high, particularly in small children. In some of the countries in Sub-Saharan Africa some parents prefer the rectal route for administration of sedative drugs. The administration of midazolam by this route may be indicated where children refuse to take oral drugs, are nauseous, vomiting, or very anxious. It can be used on its own for painless procedures or in combination with other drugs when analgesia is required. In a study, rectal midazolam administered at 1 mg/kg to children 30 min before dental surgery achieved satisfactory sedation and recovery whilst maintaining hemodynamic stability.


Table 25.3
Dosing schedule for midazolam








































Route

Dose (mg/kg)

Maximum dose

Time to peak effect (min)

Duration of action (min)

Oral

0.35

7.5 mg

10–30

60

Nasal

0.3–0.5

0.5 mg/kg

10–20

60

Rectal

0.5–1

1 mg/kg

10–15

60–90

Intravenous

0.025–0.1

1 mg

3–5

20–60


Reprinted with permission from Reed A, Thomas J, Roelofse JA, Gray R, de Kock M, Piercy J. Paediatric Procedural Sedation and Analgesia (PSA) Guidelines; South African Society of Anaesthesiologists. 2011

Rectal diazepam is a useful and cost-effective alternative sedative for midazolam, especially in rural areas, where the latter drug is often not available. Rectal diazepam, at a dose of 0.70 mg/kg, provides acceptable levels of sedation, and patient acceptance, when administered 30 min before a procedure [25]. Rectal ketamine at a dose of 5 mg/kg has also successfully been used in dental surgery and may be a useful alternative for pediatric sedation [26].


Intravenous Route: Single Agent


Any sedation administered by the intravenous route, using bolus or infusion techniques should be considered an advanced sedation technique [15], and should be administered by suitably trained and equipped personnel. Intravenous agents can be used as small boluses titrated to effect or as a continuous infusion. Unadjusted continuous infusion techniques may result in gradually rising plasma concentrations of sedative and necessitate constant intensive monitoring and airway vigilance.

Propofol is a short-acting phenol derivative. Its use as a sedative hypnotic agent outside the operating room remains contentious. Propofol has a narrow therapeutic index and the sedation practitioner should anticipate that deep sedation, airway obstruction, and apnea may occur rapidly and unpredictably. Although it is an effective sedative, it should be used only for brief procedures, as repeated doses or infusions are more likely to be associated with adverse events. The usual sedative dose in children is 0.3–0.5 mg/kg titrated to effect with a titration interval of at least 1 min. Target Controlled Infusion (TCI) of propofol may overcome some of the limitations of continuous infusions [27, 28]. TCI is an infusion controlled by a real-time pharmacokinetic model that employs algorithms to construct a variable rate infusion. (Refer to Chap. 31.) Two algorithms are available in South Africa: the Kataria and Paedfusor models. The Kataria model caters to children over the age of 3, whereas the Paedfusor model may be used in children over a year of age [29, 30]. As the effect site equilibration constant is not known in children, both models only allow use as plasma targeting. Usual plasma targets for sedation are between 0.5 and 2 mcg/mL, but like bolus dosing should be titrated to effect.

Ketamine is probably the most widely used single intravenous sedative in the developing world. Ketamine induces a state of cortical dissociation with profound analgesia, sedation, and amnesia. At typical sedative doses, there is relative preservation of airway reflexes and tone. Emergence delirium is less common in children, and of a much smaller magnitude than adults and it correlates significantly with the degree of pre-procedural agitation. See Table 25.4 for dosing recommendations.


Table 25.4
Dosing schedule for ketamine














































Route

Dose

Onset (min)

Time to peak effect (min)

Duration of action

Oral

2–5 mg/kg

5–10

20

4 h

Nasal

2–5 mg/kg

5–10

20

4 h

Rectal

2–5 mg/kg

5–10

20

4–6 h

Intravenous bolus

0.25–1 mg/kg

<1

3–5

10–15 min

Intravenous infusion

0.5–1 mg/kg/h

<1

3–5

10–15 min


Reprinted with permission from Reed A, Thomas J, Roelofse JA, Gray R, de Kock M, Piercy J. Paediatric Procedural Sedation and Analgesia (PSA) Guidelines; South African Society of Anaesthesiologists. 2011

Midazolam is a short-acting benzodiazepine with potent amnestic, sedative, and anxiolytic properties. Paradoxical agitation may occur in up to 1.4 % of children and may necessitate treatment with flumazenil and use of an alternative agent. When given intravenously, most children should require no more than 1 mg [15]. See Table 25.3 for dosing recommendations.

Dexmedetomidine is an alpha 2-receptor agonist that has the ability to provide sedation without causing respiratory depression. A biphasic dose–response effect on hemodynamics has been described, characterized by decreases in arterial blood pressure and heart rate at low plasma concentrations and an increase in arterial blood pressure with further reductions in heart rate at higher plasma concentrations [31]. To minimize the hemodynamic effects of dexmedetomidine, the loading dose of 1 mcg/kg should be given as a slow intravenous injection over at least 10 min. This can be followed by a constant infusion of 0.2–0.7 mcg/kg/h.


Oral Route: Sedative and Analgesic Combination


No single drug is available that meets all the requirements of an ideal sedative. Drug combinations may therefore be necessary, particularly in the management of uncooperative children. Drug combinations do, however, increase the risk of complications and the sedation practitioner involved should be trained in advanced sedation techniques, and preferably have experience in general anesthesia. A combination of midazolam and ketamine is useful for sedation in short, painful procedures. Oral midazolam (0.35 mg/kg) combined with oral ketamine (5 mg/kg), in children has been shown to provide safe, effective, and practical sedation for minor oral surgical procedures under local anesthesia [32]. When oral ketamine and midazolam are used, in conjunction with an intravenous technique, the dose of oral ketamine should be reduced to 2 mg/kg. This dose of ketamine is also suitable for children under the age of 2 years [33] but they need to be monitored carefully for over sedation.

The safe and effective management of children for painful procedures outside the operating room remains a challenge. Dental procedures are common pediatric day-cases and are one of the commonly used research models used for studying the efficacy of minor analgesic agents [34]. Severity of postoperative pain is related to the number of teeth extracted, and an effective clinical research model has been established by studying children who have undergone six or more extractions [35]. This study gives valuable information regarding pain after pediatric dental procedures. Children aged 4–7 years, undergoing six or more dental extractions, received tramadol (1.5 mg/kg) or placebo 30 min before surgery. Both groups furthermore received oral midazolam (0.5 mg/kg) up to a maximum of 7.5 mg 30 min before surgery. Postoperative rescue analgesia was required by 19.4 % of the tramadol group, compared with 82.8 % of the placebo group [35]. This showed that the use of effective analgesic drugs, before sedation, minimized postoperative pain in children. Other studies have confirmed tramadol’s analgesic efficacy, lack of significant respiratory depression and preservation of time to recovery when used in combination with other sedative agents [36, 37]. The combination of oral tramadol 1.5–3 mg/kg with midazolam is a useful combination for sedation and analgesia for children undergoing painful procedures outside the operating room. Another useful oral combination is trimeprazine (6 mg/mL) and methadone linctus (0.4 mg/mL) in a syrup base [23, 32]. The usual oral dose is 0.5 mL/kg of the mixture up to a maximum of 10 mL. This can be used as sedation for small, painful surgical procedures where local anesthesia is to be used. It is also a useful sedative combination for painless procedures as profound sedation is achieved. Unfortunately methadone, an opioid and trimeprazine a phenothiazine derivative have long elimination half-lives resulting in prolonged recovery. However, despite these limitations, the low cost of this combination makes it useful for oral pediatric sedation in the developing world. Deeper levels of sedation can be obtained by adding droperidol (0.1 mg/kg) to the mixture.

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