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From the Department of Anesthesiology, N.R.S. Medical College, Calcutta, India.
Address correspondence to: Dr. Manjushree Ray, 12/1, A. K. Point, 68B, A.P.C. Roy Road, Calcutta-700 009, India. Phone: 91-33-350-6943; Fax: 91-33-246-7722; E-mail: manjushriray{at}hotmail.com
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Abstract |
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Methods: Thirty-two children aged four to eight years, ASA physical status I and II were included in this prospective randomized controlled study.
In the postoperative care unit, patients were allocated to receive fentanyl, using a double-blind study design, either intranasally (Group I) or intravenously (Group II) in small titrated doses until they became pain free or side effects appeared which prohibited continuation of the drug.
Results: Satisfactory analgesia was achieved in both groups, though the required drug dosage was higher in the intranasal group (1.43 ± 0.39 µg•kg-1). Onset of analgesia tended to be slower via the intranasal route compared to the iv route (13 ± 4.5 vs 8.3 ± 3.08 min; P=not significant). Side effects observed in this series were within an acceptable range and similar for both modalities.
Conclusion: The intranasal route provides a good alternative for administration of fentanyl in pediatric surgical patients.
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Introduction |
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The aim of this study was to investigate the efficacy of intranasal fentanyl for postoperative analgesia in children and to determine whether this route provides a fast onset of pain relief and allows titration of dose according to the child's needs.
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Methods |
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Patients were fasted for three to four hours and premedicated with oral midazolam 0.5 mg•kg-1 of body weight. EMLA® cream was applied at the proposed site of iv cannulation one hour before surgery.
After applying standard monitors, an iv cannula was inserted and atropine 0.02 mg•kg-1 was administered. General anesthesia was induced with halothane and nitrous oxide in oxygen via face mask. IV vecuronium bromide 0.1 mg•kg-1 was administered to facilitate orotracheal intubation. After intubation anesthesia was maintained with oxygen, nitrous oxide, 0.5% halothane, and top up doses of vecuronium bromide. Intraoperative analgesia was provided by repeated doses of fentanyl citrate (1 µg•kg-1) q 30 min. At the end of the surgical procedure residual neuromuscular blockade was reversed with neostigmine and atropine and patients were transferred to the postanesthetic care unit (PACU).
In the PACU, patients were assessed for intensity of postoperative pain with the Hannallah pain scale2 (Table I
). Patients with Hannallah pain score 4 or more were included in this study and randomly allocated to receive fentanyl citrate by the intranasal route (Group I) or the iv route (Group II).
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During the entire procedure an observer, totally unaware of the nature of the study, monitored heart rate, systolic arterial pressure, respiratory rate, sedation, intensity of pain using the Hannallah scale and hemoglobin oxygen saturation.
All patients were monitored clinically for hemodynamic stability and respiratory adequacy in the recovery room. Patients were also observed for side effects like nausea, vomiting, itching and excessive sedation.
Results are expressed as mean values ± SD. To analyse differences between the two groups for demographic profile, intensity of pain, onset of analgesia and requirement for fentanyl, Student's t test was used. Chi square test was used for qualitative data. A P <0.05 was considered statistically significant.
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Results |
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. The two groups were similar with respect to age, weight, heart rate, systolic arterial pressure, respiratory rate and hemoglobin oxygen saturation (Table II). Before administration of fentanyl, intensity of postoperative pain was also similar in both groups (P=not significant; Table III).
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) and there was no need to discontinue the study in any patient because of insufficient pain relief after 30 min. Complete analgesia was achieved within 13.0 ± 4.5 min in the intranasal group compared to 8.3 ± 3.08 min in the iv group (P=not significant).
Occurrence of side effects was also similar in the two groups (Table IV). Three patients became hypoxic in this series but they responded well to oxygen therapy.
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Discussion |
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Although the pharmacokinetics of fentanyl by the intranasal route have not been evaluated, lipophilic agents with a low molecular weight produce plasma levels similar to those achieved by the iv route.6 Thus, fentanyl might exhibit a similar pharmacokinetic profile when administered intranasally and intravenously.
Quality of analgesia following intranasal administration was comparable to that after iv administration, but doses required were significantly increased. Our observation differs from that reported by Striebel and co-workers.7 Requirement of drug by the intranasal route was almost the same as that by the iv route in their series. A possible reason may be the way we administered the drug. In the present series, the drug was instilled in the nasal cavity drop by drop with a needle and syringe while Striebel7 and other investigators used a spray. Therefore, dispersion of the drug in small particles and subsequent absorption and bioavailability was probably enhanced in their series. Helmers8 and Vercauteren9 also suggested a higher bioavailability of sufentanil after intranasal administration. This higher bioavailability is due to direct entrance of the drug into the systemic circulation and avoidance of the hepatic first-pass effect.
Intranasal fentanyl does not irritate the nasal mucosa and has a very low ciliotoxic effect, hence the drug may be used for prolonged periods without any adverse effect.10 None of our patients complained of pain or burning sensation in the nose following instillation of fentanyl.
Side effects such as nausea, vomiting and hypoxia observed in this series, were within an acceptable range and responded well to conventional therapy. One patient in the iv group and two in the intranasal group became hypoxic (SpO2 <90%). They were treated successfully by nasal oxygen. Respiratory depression was not apparent in these patients either in the form of low respiratory rate or tidal volume. Hence, fentanyl was possibly not the cause of hypoxia.
In summary, intranasal and iv fentanyl both provide effective postoperative analgesia in pediatric patients and their safety profile is similar.
Revision received November 15, 2001. Accepted for publication July 4, 2001.
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References |
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2 Hannallah RS, Broadman LM, Belman AB, Abramowitz MD, Epstein BS. Comparison of caudal and ilioinguinal/iliohypogastric nerve blocks for control of post-orchiopexy pain in pediatric ambulatory surgery. Anesthesiology 1987; 66: 832–4.[Medline]
3 Wilton NCT, Leigh J, Rosen DR, Pandit UA. Preanesthetic sedation of preschool children using intranasal midazolam. Anesthesiology 1988; 69: 972–5.[Medline]
4 Henderson JM, Brodsky DA, Fisher DM, Brett CM, Herztka RE. Preinduction of anesthesia in pediatric patients with nasally-administered sufentanil. Anesthesiology 1987; 69: 495.
5 Walbergh EJ, Wills RJ, Eckhert J. Plasma concentration of midazolam in children following intranasal administration. Anesthesiology 1991; 74: 233–5.[Medline]
6 Hussain A, Foster T, Hirai S, Kashihara T, Batenhorst R, Jones M. Nasal absorption of propranolol in humans (Letter). J. Pharm Sci 1980; 69: 1240.
7 Striebel HW, Pommerening J, Rieger A. Intranasal fentanyl titration for postoperative pain management in an unselected population. Anaesthesia 1993; 48: 753–7.[Medline]
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Helmers JHJH, Noorduin H, Van Peer A, Van Leeuwen L, Zuurmond WWA. Comparison of intravenous and intranasal sufentanil adsorbtion and sedation. Can J Anaesth 1989; 36: 494–7.
9 Vercauteren M, Boeckx E, Hanegreefs G, Noorduin H, Vanden Bussche G. Intranasal sufentanil for pre- operative sedation. Anaesthesia 1988; 43: 270–3.[Medline]
10 Peng PWH, Sandler AN. A review of the use of fentanyl analgesia in the management of acute pain in adults. Anesthesiology 1999; 90: 576–99.[Medline]
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