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 Table of Contents  
Year : 2022  |  Volume : 9  |  Issue : 2  |  Page : 156-162

Applicability of Ambulatory Cleft Lip Repair in North-western Nigeria: Case Series and Review of the Existing Literature

1 Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, Usmanu Danfodiyo University, Sokoto, Nigeria; Resmile Craniomaxillofacial Anomalies Foundation Zamfara
2 Department of Dental and Maxillofacial Surgery, Usmanu Danfodiyo University Teaching Hospital, Sokoto, Nigeria
3 Department of Dental and Maxillofacial Surgery, Usmanu Danfodiyo University Teaching Hospital, Sokoto, Nigeria; Resmile Craniomaxillofacial Anomalies Foundation Zamfara
4 Department of Dental and Maxillofacial Surgery, Federal Medical Centre, Gusau, Nigeria
5 Department of Dental and Maxillofacial Surgery, Federal Medical Centre, Birnin-Kudu, Jigawa, Nigeria
6 Department of Dental and Maxillofacial Surgery, Federal Medical Centre, Birnin Kebbi, Nigeria
7 Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, College of Medicine, University of Lagos, Ilorin, Nigeria
8 Department of Surgery, University of Ilorin/University of Ilorin Teaching Hospital, Ilorin, Nigeria
9 Department of Dental and Maxillofacial Surgery, Sir Yahyah Memorial Specialist Hospital, Birnin Kebbi, Nigeria

Date of Submission10-Mar-2022
Date of Acceptance06-Jun-2022
Date of Web Publication23-Aug-2022

Correspondence Address:
Dr. Abdulrazaq Olanrewaju Taiwo
Department of Oral and Maxillofacial Surgery, Faculty of Dental Sciences, College of Health Sciences, Usmanu Danfodiyo University, PMB 12003, Sokoto

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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jclpca.jclpca_4_22

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Objective: To report the applicability of ambulatory cleft lip repair (CLR) and to review the existing literature. Materials and Methods: This is a retrospective clinical case series study of ambulatory CLR in North-western Nigeria. The study was carried out in Usmanu Danfodiyo University Teaching Hospital (UDUTH), Sokoto, between January 2012 and December 2018. Relevant clinical data of the subjects obtained include sociodemographics, type of cleft, and complications. Protocol employed includes premedication with diazepam (0.5 mg/kg, IV) slowly, followed by administration of glycopyrrolate (0.005 mg/kg, IV) and diclofenac potassium (1 mg/kg, IV). Then, ketamine (0.1 mg/kg, IV) was infused slowly over a 5-min period to achieve procedural sedation (Ramsey sedation score of 3). The data were analyzed using (SPSS; Chicago, IL, USA) program, version 20. The results were presented in simple descriptive statistics. Results: The age ranged from 2 to 21 years with male preponderance (M: F = 4:1). All participants had unilateral clefts lip with or without alveolus. The left side was twice involved as the right. There were no perioperative complications nor mortality recorded and no patient required conversion to general anesthesia. All patients were successfully discharged home on the same day of the operation. No case of readmission was recorded and subsequent follow-up was uneventful. Conclusions: Parenteral use of ketamine and diazepam for outpatient pediatric cleft lip procedures is safe and of immense benefits in reducing the surgical cleft burden without compromising patients safety.

Keywords: Ambulatory, cleft lip, ketamin, safety, sedation

How to cite this article:
Taiwo AO, Braimah RO, Ibikunle AA, Adigun OI, Lawal SH, Ile-Ogendengbe B, Bala M, Olayinka AM, Adeyemi MF, Farouk MA. Applicability of Ambulatory Cleft Lip Repair in North-western Nigeria: Case Series and Review of the Existing Literature. J Cleft Lip Palate Craniofac Anomal 2022;9:156-62

How to cite this URL:
Taiwo AO, Braimah RO, Ibikunle AA, Adigun OI, Lawal SH, Ile-Ogendengbe B, Bala M, Olayinka AM, Adeyemi MF, Farouk MA. Applicability of Ambulatory Cleft Lip Repair in North-western Nigeria: Case Series and Review of the Existing Literature. J Cleft Lip Palate Craniofac Anomal [serial online] 2022 [cited 2022 Dec 8];9:156-62. Available from: https://www.jclpca.org/text.asp?2022/9/2/156/354294

  Introduction Top

The enormous burden of inpatient orofacial cleft management under general anesthesia has generated concern, especially in low- and low-middle income countries (LMICs) of sub-Saharan Africa.[1],[2],[3],[4] This is as a result of palpable shortfall in population-wide health insurance coverage, acute theater space deficiency, desperate shortage in cleft care personnel including surgeons, anesthesiologist, and operative room personnel.[3],[5],[6],[7] In addition, user fee-based health system with few on health insurance has made indigent patients in resource-limited setting not able to afford hospital fee. Therefore, the attendant heavy pressure on the already over-stretched fragile health system might increasingly shift attention to outpatient day case surgery also called ambulatory surgery.[5],[6],[7],[8] The question of improved safety standard cannot be over-emphasized while conserving resources, therefore improved safety, increased efficiency, and reduction in economic burden on patients have made ambulatory surgeries more popular, especially in resource-limited settings.[8],[9]

Thus, ambulatory cleft lip repair (CLR) under ketamine sedation has been in ascendency in the global community.[5],[7],[8],[10] However, across Africa including Nigeria, there is dearth of studies probing its safety and practicability. Therefore, the purpose of this research was to scrutinize the feasibility of ambulatory CLR at Usmanu Danfodiyo University Teaching Hospital (UDUTH), Sokoto, Nigeria.

  Materials and Methods Top

This was a retrospective study of patients that had CLR at the outpatient oral and maxillofacial surgery clinic of the UDUTH, Sokoto from January 2012 to December 2018. Ethical permission for the study was obtained from the Health Research Ethics Committee of UDUTH with protocol number UDUTH/HREC/2022/1144/VI. Relevant clinical data of the participants obtained include: type of cleft, type of anesthesia, complications, length of hospital stay, and rate of re-admission before the first follow up visit. The inclusion criteria for day case surgery were; patients with either an American Society for Anesthesiology (ASA) I or II, certified fit for anesthesia and surgery by the anesthetist, absence of pulmonary problems, hematocrit not <30%, must not be <24 month old, children and adults must have avoided solid foods 6 h to surgery; however, they were encouraged to drink clear fluids up to 2 h before surgery according to the European guidelines on peri-operative fasting (endorsed by the Association of Anesthetists),[11] present at the hospital in the morning of the surgery and adequate competent home supervision following surgery is ensured. The exclusion criteria include consent refusal, syndromic cleft, bilateral cleft, cleft palate, psychiatric disorder like schizophrenia, allergies to local anesthetics, sedatives, major comorbidities such as sickle cell anemia, blood dyscrasias, cardiac, respiratory (asthma and COPD), liver and renal diseases. Other excluded criteria are patients on anticoagulants, systemic steroids, immune-suppressants and metabolic disorders. All included patients had primary cheilorraphy under conscious sedation and local anesthesia. Millard technique was used exclusively.

The patients underwent a preanesthetic evaluation that included a thorough airway examination both by the anesthetists and surgeons who were consultants and senior registrars with experience in both conscious sedation and general anesthesia. The procedures of conscious sedation and lip repair were explained to each patient before taken informed consent for sedation and surgery with the assurance of the presence of an anesthetist in case of any form of emergency. Also available in the dental clinic is an oxygen tank, pulse oximeter, blood pressure machine, high vacuum suctioning machine, endotracheal tube, Guedel airway, nasopharyngeal airway, and Ambu bag in case of any form of emergency [Figure 1]. After obtaining baseline parameters, such as pulse rate, temperature, respiratory rate, noninvasive blood pressure and oxygen saturation; a peripheral line was secured after the application of topical anesthesia for intravenous infusion of 0.9% normal saline. The patients were properly positioned on the dental operating unit [Figure 2] at 45° and neck supported by the head rest of the unit with constant suctioning of the oral cavity to prevent any form of fluid and saliva aspiration.
Figure 1: Emergency table showing resuscitating equipment's (oxygen tank, pulse oximeter, blood pressure machine, endotracheal tube, Guedel airway, nasopharyngeal airway, and Ambu bag)

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Figure 2: Clinic setting showing the dental operating unit with head and neck components and high vacuum suctioning machine

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All medications were given by the consultant oral and maxillofacial surgeon who has training in conscious sedation and who takes medical responsibilities for the patient despite the presence of an anesthetist on standby in case of emergency. Each patient was premedicated with diazepam (0.5 mg/kg, IV) which was given slowly, followed by the administration of glycopyrrolate (0.005 mg/kg, IV), and diclofenac potassium (1 mg/kg, IV). Then, ketamine (0.1 mg/kg, IV) was infused slowly over a 5-min period to achieve procedural sedation (Ramsey sedation score of 3). Bilateral loco-regional block of the infraorbital nerve was achieved with Lignocaine hydrochloride with adrenaline (2%; 1:80,000) at 3–7 mg/kg which was supplemented with infiltration in the lip tissue. All patients received parenteral Ceftriazone (500 mg, IV) and metronidazole (500 mg, IV) 30 min before knife on the skin. Surgery time in all the patients was less than an hour; therefore, no patient required additional sedation. In addition, the lead surgeon is a specialist in the repair of facial clefts and surgery time was similar under ambulatory and general anesthetic conditions.

Constant verbal communication was maintained with the patient throughout this period. Monitoring of the patient's vital signs by the nursing staff continued after surgery, attainment of satisfactory hemostasis, and stable spontaneous respiration. Indication of full consciousness was assessed using the Ramsey Sedation Scale.[12] This scale is graded from 1 to 6 (1-Patient is anxious and agitated or restless, or both, 2-Patient is co-operative, oriented, and tranquil, 3-Patient responds to commands only, 4-Patient exhibits brisk response to light glabellar tap or loud auditory stimulus, 5-Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus, 6-Patient exhibits no response). All patients had Ramsey Score of 1 before transfer to recovery area.

Pulse oximeter and blood pressure cuff was connected to the patients until point of discharge when they were fully conscious, well orientated, can tolerate oral fluids and walk with minimal assistance. Contact details between the patients' guardians and operating team were exchanged and phone communication was maintained postoperatively. Subsequent reviews were carried out appropriately.

Analysis was done using SPSS program (version 15)(IBM SPSS statistics for windows, version 15.0. Armonk, NY: IBM Corp; 2010) and descriptive statistic carried out and presented in a tabular form.

  Results Top

A total of 10 (8 males and 2 females) subjects were recruited during this period. The age ranged from 2 to 21 years with male preponderance (M: F = 4:1). All subjects had unilateral clefts lip with or without alveolus. Left side was twice involved as the right. There were no perioperative complications nor mortality recorded and no patient required conversion to general anaesthesia. Vital signs of participants preoperative, intra-operative, postoperative and before discharge home were within normal limits [Table 1]. All patients were successfully discharged home on same day of the operation. No case of readmission was recorded and subsequent follow up was uneventful [Figure 3]a and [Figure 3]b and [Figure 4]a and [Figure 4]b.
Figure 3: (a and b) Pre- and postoperative clinical photographs of a 9-year-old male child operated under ambulatory cleft lip repair.

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Figure 4: (a and b) Pre- and postoperative clinical photographs of a 7-year-old female child operated under ambulatory cleft lip repair.

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Table 1: Distribution of vital signs at baseline, intraoperative and time of discharge

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  Discussion Top

Worldwide, most pediatric cleft lip and palate surgeries are performed under general anesthesia.[13],[14] In developing low LMIC of sub-Saharan Africa, sedation for pediatric surgical procedures has been used effectively in outpatient office or emergency settings.[5],[8] In these resource constrained settings, heavy cost of general anesthesia and bed fee charges has further limited its use. Consequently, attention has been shifted to ambulatory surgeries which is far more affordable.[8],[9] While accentuating on cost reduction, the question of improved safety standard cannot be over-emphasized. Therefore, reported improved safety, increased efficiency and reduction in economic burden on patients have made ambulatory surgeries more popular especially in resource limited settings.[8],[9]

Conscious sedation is especially favored over deep sedation as it enables the depression of consciousness to such a level that the patient is awake, breath spontaneously, retains protective pharyngeal reflexes and respond to commands throughout the duration of the surgery.[15],[16],[17],[18],[19],[20] Its track record of safety has endeared for use in various procedures that cut across several medical, surgical and dental disciplines.[6],[15],[18],[20] The current study restricted itself to ASA I to ensure safety and avoidance of any adverse outcome. Furthermore, those with bilateral cleft lip, syndromic cleft and cleft palate were excluded from the study in agreement with previous works that shown them to be poor candidates for ambulatory surgical procedure.[20],[21],[22],[23]

Children have been reported to be at significant risk of loss of airway reflexes and developing hypoxia during general anesthesia or deep sedation.[24],[25],[26] Hodges and Hodges in an earlier study limited cleft surgery under sedation for those above 10 years[27] however, Bello and colleagues demonstrated the safety of ambulatory outpatient sedation in cleft children <10 years old.[5] In the present study, the mean age of 11 years was recorded with the youngest patient being 2 years old. This particular 2-year-old patient had incomplete cleft of the lip, therefore extent and duration of surgery was very minimal. Additionally, this patient was placed on the fathers' lap while the father sat on the dental chair.

While trying to conserve resources, good patient selection is very essential in ambulatory CLR to maintain safety and overall wellbeing of these patients.

The literature reported that 10%–20% of adult experienced emergence delirium and hallucination with ketamine but a very rare findings in children below 16 years which in the current study this complications was not observed.[18],[28] This has been blamed on the fact that the NDMA receptors that ketamine noncompetitively antagonize is less prevalent in adults than children.[18],[29]

Patients' early recovery and discharge is the hallmark of ambulatory outpatient sedation. The drugs of choice must possess outstanding safety profile that guards against complete loss of consciousness, great potency and guarantee short recovery time. Ketamine fits the above for ambulatory cleft lip surgery in a Nigerian study.[5] Ketamine is a structural analogue of phenycyclidine (arylcyclohexylamine), consists of racemic mixture of two enantiomers S(+) and R (-); and highly lipophilic.[10],[15],[18],[22],[30] It binds multiple sites but principally noncompetitively antagonize N-methyl-D-aspartate (NMDA) receptor.[10],[18],[30] Other sites include non-NMDA glutamate receptors, nicotinic/muscarinic cholinergic receptors, μ and κ receptors and sodium, potassium and calcium channel. Mechanism of action is primarily on the cortical and limbic systems causing functional dissociation (cataleptic state, cardiovascular stability, protective airway maintenance, bronchodilation, sedation, analgesia and amnesia).[18],[30],[31] Spontaneous respiration, preservation of airway and reflexes like corneal, coughing, pharyngeal, laryngeal and swallow are uniquely conserved during this state.[18],[30],[32] It retains one tenth potency of phencyclidine psychokinetic effects but in sub-anesthetic doses its hallucinogenic effects is further lessened by the addition of benzodiazepines which also prolongs its activity beyond 15–30 min.[33],[34],[35]

Previous studies thought that ketamine produces central sympathetic stimulation but recent work demonstrated that this is not the case as it instead locally prevents the re-uptake of catecholamines.[18],[20],[31] However, it can work synergistically in combination with other agents that have the opposite effect like benzodiazepines (diazepam or midazolam) or propofol.[30],[31],[34],[35] It can be utilized in minute boluses or infusion for conscious sedation. In the current study diazepam was added to ketamine, stable cardiopulmonary response, preservation of protective airway reflexes and spontaneous breathing was achieved without any serious complication reported. Doses between 200 and 750 μg/kg have been recommended to be effective for ketamine sedation.[30],[32],[33] But for continuous infusion 5–20 μg/kg/min is the choice or 2–4 mg if intramuscular route is chosen.[18],[30],[33] The study administered a reduced dose of 100 μg which was quite effective. Diazepam is a lipid soluble benzodiazepine with agonist effect on the Gabanergic receptor causing anxiolysis, sedation, anterograde amnesia, anticonvulsant, muscle relaxation, hypotension and respiratory depression.

Drugs were administered intravenously in the present work in tandem with earlier studies. However, some investigators have also demonstrated efficacy with the oral or rectal route. ketamine demonstrates superior bioavailability (93%), <1 min peak plasma concentration and up to 30 min duration of action when administered intravenously.[18],[30] Ketamine bioavailability are oral (17%–20%), intranasal (25%–50%), sublingual (30%) and rectal (30%).[29],[30],[31],[33] For oral and intramuscular peak plasma concentration are reached 30 min and 5–10 min. Duration of action in a clinical setting is 4–6 h and 30 min to 2 h intramuscularly respectively.[29],[30],[35] The drawbacks of other routes also include unpredictability and use of higher doses required to achieve satisfactory sedation.

Successful use of various local anesthetics such as bupivacaine, mepivacaine and others for infiltration and regional anesthesia have been demonstrated in upper extremity, cranial and third molar surgeries.[1],[5],[6],[8],[17] The use of ketamine and diazepam in our study helped to reduce the pain and phobia of lignocaine administration. Vice versa, local anesthetic injection might also have contributed to the reduction in the doses of sedatives, control of hemostasis, reduction of blood loss and maintenance of intra-and postoperative analgesia. Besides, the addition of local anesthetic to sedation extracted more cooperation from the patients without the risk of losing consciousness and delicate spontaneous airway control. It also helps to reduce the postoperative analgesic consumption, readmission, and need for prolonged postoperative monitoring.

The study employed aminopyrollate as antisialogogue to counteract the hypersalivation induce by ketamine administration, thus, mitigating the risk of laryngospasm. This antimuscarinic and anticholinergic agent is far more potent than atropine and scopolamine.[30],[34] Moreover, unlike its predecessors cause mild tachycardia and does not cross the blood brain barrier.[15],[16],[30] Moreover, diligent suctioning of the oral secretions during procedure was done to also lessen the risk of coughing, aspiration and eventually laryngospasm.

Adding benzodiazepine to ketamine helps to attenuate the incidence of its deleterious psychotomimetic side effects such as emergence delirium, hallucination, and hypertension.[26],[28],[30],[35] Others are postoperative nausea, vomiting, excessive salivation, tonic − clonic movement, nystagmus, and diplopia.[18],[30],[31],[36] Although midazolam is more popular than diazepam due to its water solubility, short acting, greater potency, excellent sedative-hypnotic effect without any significant side effects and does not produce active metabolites such as diazepam that produces nordiazepam and temazepam, especially when administered orally.[18],[30],[32],[33] This present research, utilized diazepam intravenously because it is readily available, easily affordable and most clinical staff are well trained in its use in most resource challenged setting.[37]

In the present research, sedation was performed by oral and maxillofacial surgeon and assisted by a dental surgeon and dental nurse which contradicts the claim by some quarters that intravenous sedation should only be performed by anesthetists.[35],[36],[38] It is in concordance with many studies of sedation supervised by oral and maxillofacial surgeons and nonanaesthetists medical personnel such as nurses, physicians, surgeon and dentists.[4],[5],[6],[21],[22],[30],[32],[33],[34] The study did not record any major complication such as emergence reaction, hypertension, tachycardia, visual hallucinations, vivid dreams, tonic − clonic movements, nystagmus, and diplopia. As strict adherence to proper pre, intra and postoperative sedation protocol coupled with the use of the standard monitoring equipment's were ensured. In addition, an anesthetist was always on stand-by in case of any need to convert to general anesthesia.

  Conclusions Top

The result of this demonstrated that the parenteral use of ketamine and diazepam for outpatient pediatric cleft lip procedures is safe and of immense benefits in reducing the surgical cleft burden of a resource challenge set up like ours. However, careful case selection, strict compliance with safety protocol, provision of proper equipment's, and trained personnel are essential to avoid the development of any serious adverse outcome. A larger multicenter study is recommended to further confirm the findings of this study.

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Conflicts of interest

There are no conflicts of interest.

  References Top

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  [Figure 1], [Figure 2], [Figure 3], [Figure 4]

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