Acta Pædiatrica ISSN 0803–5253
REGULAR ARTICLE
Sedation with intranasal midazolam of Angolan children undergoing invasive procedures Lumana Kawanda1,*, Ivan Capobianco2,*, Meta Starc2, Daniel Felipe1, Davide Zanon2, Egidio Barbi2, Nadine Munkela1, Verónica Rodrigues1, Lúis Malundo1 and Tarcisio Not (
[email protected])2 1.Divina Provide´ncia Hospital, Luanda, Angola 2.Institute for Maternal and Child Health – IRCCS-Burlo Garofolo – Trieste, University of Trieste, Italy
Keywords Developing country, Paediatricians, Pain management, Pain reduction Correspondence Tarcisio Not, M.D., Children Hospital IRCCS ‘‘Burlo Garofolo’’, Via dell’Istria 65 ⁄ 1, IT-34100 Trieste, Italy. Tel: +39 040 3785 472 | Fax +39 040 3785 210 | Email:
[email protected] Received 31 January 2012; accepted 22 March 2012 DOI:10.1111/j.1651-2227.2012.02691.x *These two authors equally contributed to the study.
ABSTRACT Aim: Ambulatory surgery is a daily requirement in poor countries, and limited means and insufficient trained staff lead to the lack of attention to the patient’s pain. Midazolam is a rapid-onset, short-acting benzodiazepine which is used safely to reduce pain in children. We evaluated the practicability of intranasal midazolam sedation in a suburban hospital in Luanda (Angola), during the surgical procedures. Methods: Intranasal midazolam solution was administered at a dose of 0.5 mg ⁄ kg. Using the Ramsay’s reactivity score, we gave a score to four different types of children’s behaviour: moaning, shouting, crying and struggling, and the surgeon evaluated the ease of completing the surgical procedure using scores from 0 (very easy) to 3 (managing with difficulty). Results: Eighty children (median age, 3 years) were recruited, and 140 surgical procedures were performed. Fifty-two children were treated with midazolam during 85 procedures, and 28 children were not treated during 55 procedures. We found a significant difference between the two groups on the shouting, crying and struggling parameters (p < 0.001). The mean score of the ease of completing the procedures was significantly different among the two groups (p < 0.0001). Conclusion: These results provide a model of procedural sedation in ambulatory surgical procedures in poor countries, thus abolishing pain and making the surgeon’s job easier.
INTRODUCTION Ambulatory surgery is a common daily requirement in poor countries (1), but limited means and insufficient trained staff lead to the lack of attention to the patient’s pain and how to manage it (2). In addition, the procedures performed in that context (e.g. closed reduction of fracture, incision and drainage of abscess) (2) are usually more painful and invasive than those performed in a similar setting in developed countries. Midazolam is a rapid-onset, short-acting benzodiazepine which was used successfully and safely in a variety of paediatric clinical situations (3). The intranasal route is preferable as it obviates the need for intravenous access, is easily accessible and has a more rapid rate of absorption compared to the oral route (3,4). We carried out a prospective observational clinical study to evaluate the practicability of intranasal midazolam (INM) sedation in a suburban hospital in Luanda (Angola) with an outpatients’ clinic for minor surgical procedures and no trained anaesthetists.
MATERIAL AND METHODS Subjects and study design In the context of a cooperation agreement (beginning 2002) between the paediatric university department of the Burlo
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Garofolo children’s hospital and the Divina Provide´ncia hospital in Luanda, we set up a pilot study in Luanda from July to October 2011 called ‘No Children, No Cry’. All children and adolescents admitted to hospital who needed a surgical or invasive procedure were recruited. The airway was inspected for abnormalities (e.g. obstructive tonsils, large tongue, laryngomalacia, micrognathia and ongoing respiratory infection) that could impair airway management. Unconscious children were excluded. The procedure’s possible discomforts and benefits were explained to children and parents, who provided spoken consent. The
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In the developing countries, a high proportion of children undergo invasive procedures, and the acute pain relief is absent or inadequate. Intranasal midazolam is used safely as a sedative shortacting benzodiazepine in children undergoing painful invasive procedures. The intranasal midazolam is a cheap and effective way to treat pain in children during surgical procedures in poor countries, when anaesthetists are not available, as well as making the surgeon’s job easier.
ª2012 The Author(s)/Acta Pædiatrica ª2012 Foundation Acta Pædiatrica 2012 101, pp. e296–e298
Kawanda et al.
Intranasal midazolam sedation in poor countries
procedure in the two study groups using scores from 0 (very easy) to 3 (managing with difficulty). Statistical analysis Mann–Whitney test was used to measure the statistical significance of the scores obtained from the two groups; a p < 0.05 was considered significant.
Figure 1 Mucosal atomiser device (MAD) connected to a 5-mL syringe.
study was approved by our hospital’s independent ethics committee (CE ⁄ V-88). For ethical considerations, we did not randomly assign the patients to receive INM or local lidocaine alone, and the participants were divided into two groups as follows: (i) children who refused sedation or who were evaluated 2 weeks before midazolam became available at the Divina Provide´ncia hospital, made up the control group, and were premedicated only with local lidocaine, when necessary, and (ii) in the case group, children were treated with INM and with local lidocaine (if a skin cut was needed). All children were weighed prior to procedure. The lidocaine was used at a dose of 2.5 mg ⁄ kg. In the INM group, lidocaine was injected after INM administration. Midazolam was provided by the Burlo Garofolo pharmacy at a concentration of 10 mg ⁄ mL, prepared as previously described (4). The INM solution was administered by a physician at a dose of 0.5 mg ⁄ kg using a syringe connected to a mucosal atomiser device (Wolfe-Tory-Medical, Salt Lake City, UT, USA) (Fig. 1), 15–30 min before the invasive procedure. The physicians (I.C., M.S.) were trained previously in Burlo Garofolo hospital in using INM procedure and in airway management (recognition of obstruction, bag-valve ventilation, cardiopulmonary resuscitation, midazolam pharmacology). All necessary age-appropriate equipment was available for airway management, including oxygen, a bagvalve mask and suction. Monitoring during the procedure took the form of close clinical observation (respiratory movements, breathing pattern, breathing noises, nodding); using a modified Ramsay’s reactivity score, the same physician (I.C.) gave a reactivity score ranging from 0 (none) to 3 (very high) to four different types of children’s behaviour: moaning, shouting, crying and struggling. (5) The surgeon himself (L.K.) evaluated the ease of completing the surgical
RESULTS Eighty children (F 38; M 42; median age, 3 years; range, 1 month–14 years) were recruited to the study, and 140 surgical procedures were performed. Fifty-two children (6 aged
