Intranasal Sufentanil/Midazolam Versus Ketamine/ Midazolam for Analgesia/Sedation: METHODS

In: Anesthesia

21 Sep 2009

The University Ethics Committee approved the study, and the parents signed written consent forms. Fifty healthy ASA status 1 children, free of any nasopharyngeal or respiratory problems, aged 5-7 years, weighing 15-20 kg, and having 6 or more teeth extracted, were eligible for participation in the study. Exclusion criteria were as follows: the use of analgesics or central nervous system depressants over the previous 24 hours; the use of anticoagulants; hypersensitivity to opioids, benzodiazepines, and ketamine, or any other medication likely to interfere with the study drugs. At a presurgery visit, patients were evaluated for inclusion, and baseline assessments (including a medical history) were performed. Patients were randomly allocated before surgery according to a computer-generated randomization list to 1 of 2 treatment groups. Children were fasted for 8 hours beforehand with only sips of clear fluid allowed 3-4 hours preinduction. In the S/M group, 25 children received intranasal sufentanil 20 |xg (50 |mg/mL, via Go MedicalR nasal spray) and intranasal midazolam 0.3 mg/ kg (5 mg/mL, via a tuberculin syringe in the other nostril) 20 minutes before the induction of anesthesia. In the K/M group, 25 children received intranasal ketamine 5 mgAg (100 mg/mL, via Go Medical nasal spray) and intranasal midazolam 0.3 mg/kg (via a tuberculin syringe in the other nostril) 20 minutes before the induction of anesthesia. Sevoflurane in nitrous oxide and oxygen was used for induction and maintenance of anesthesia. The children were all intubated and a throat pack inserted to protect the airway. The children were allowed to breathe spontaneously. They underwent dental extractions. No local anesthesia was used. A blinded observer/researcher monitored parameters. The blinded observer/researcher remained with the child from prior to drug administration until discharge from the recovery room and was unable to tell which drug combination was being administered. Patients were also observed for adverse effects like nausea, vomiting, itching, and excessive sedation.

Monitoring consisted of a Dinamap adult/pediatric noninvasive blood-pressure monitor, an Ohmeda Biox HI pulse oximeter for measuring oxygen saturation, and a continuous electrocardiogram and heart-rate monitor. Blood pressures (systolic, diastolic, mean), pulse and respiratory rates, and oxygen saturations were recorded at the following time intervals: before the start of sedation, 15 and 20 minutes after drug administration, and at 30, 60, 90, and 120 minutes postoperatively. The same anesthesiologist and the same dental surgeon carried out all the treatments and the independent observer/researcher made all the assessments. The independent observer/researcher assessed the following: the acceptability of the intranasal spray (observed scale: 1 = no defense action; 2 = defense action/weeping; 3 = refusing vehemently), the ease of mask induction (observed scale: 1 = no defense action; 2 = defense action/weeping; 3 = refusing vehemently), anxiety scores (observed scale: 1 = very anxious; 2 = alert, moderately anxious; 3 = calm, indifferent, not anxious; 4 = asleep), and sedation scores (according to Ramsay: 1 = fully awake, orientated; 2 = drowsy; 3 = eyes closed, ar-ousable to command; 4 = eyes closed, arousable to shoulder shaking; 5 = unarousable to shoulder-tip shaking).
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Patients remained in the recovery room for 4 hours after surgery, where recovery was assessed according to the Aldrete postanesthetic recovery score. Postoperative pain was assessed by the following: Oucher facial pain scale (0 = no pain, 100 = extreme pain), as eval­ uated by the mother, the child, and the observer/researcher; word graphic rating scale, as evaluated by the observer/researcher (A = no pain, В = little pain, С = moderate pain, D = severe pain); and the modified Hannalah objective pain scale. The modified Hannalah objective pain scale is a behavioral-cardiovascular checklist on which a percentage is calculated according to 6 parameters (systolic blood pressure, crying, movement, agitation, posture, and complaints of pain). The behavioral categories include crying, movement, agitation, posture, and complaints of pain (verbalization).

Any adverse reactions were noted. Children with any pain value over time more than 40 mm on a 100-mm visual analogue scale were classified as nonresponders, and those with any pain value over time of equal or less than 40 mm on a visual analogue scale as responders.
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Statistical Analysis

All tests of the significance of differences were 2-tailed and a probability of .05 or less was accepted as significant. Various tests, such as the chi-square, Kruskal-Wal-lis, and the Wilcoxon rank index, were applied. All statistical modeling and significance testing was performed using the SAS statistical package (CMS version 5.18).

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Blog invites submissions of review articles, reports on clinical techniques, case reports, conference summaries, and articles of opinion pertinent to the control of pain and anxiety in dentistry.