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Clonidine as adjuvant of bupivacaine for maxillary nerve block in cleft surgery. A randomized, prospective, double blind study.

1Echaniz Barbero G, 2Sierra P, 3Merritt G, 4De Miguel M, 5Bora P, 5Bhora N, 3Ciarallo C, 6de Nadal M, 3Ing R, 7Bosenberg A
1Sick Kids Hospital, Toronto, Ontario, Canadá; 2King Abdullah Hospital, Riyadh, Riyadh, Arabia saudí; 3Children’s Hospital Colorado, Denver, Colorado, USA; 4Hospital Universitario Vall d' Hebrón, Barcelona, Barcelona, España; 5Guwahati Comprehensive Cleft Care Center, Guwahati, Assam, India; 6Hospital Universitario Vall d' Hebron, Barcelona, Barcelona, España; 7Department Anesthesiology and Pain Management Seattle Children's Hospital and University Washington, Seattle,, Washington, USA

INTRODUCTION: Cleft surgery is related with severe postoperative pain and agitation (1). Maxillary nerve block has shown to reduce opioid consumption after cleft palate repair (2). Clonidine has been described to prolong the duration of analgesia when used as adjuvant of local anesthetics (3) and to prevent agitation after anesthesia, independently of the route of administration (4). The aim of this study was to compare a bupivacaine – Clonidine mixture versus bupivacaine alone in maxillary nerve block in both pediatric and adult population undergoing cleft lip (CL) and cleft palate (CP) surgery.
METHODS: Following institutional review board approval by Operation Smile Institutional Committee, this prospective, randomized, double-blind study included 119 consecutive patients scheduled for CL or CP repair in a single institution in Guwahati, India. All patients older than 6 months received general anesthesia and bilateral suprazygomatic maxillary nerve block. Patients were ramdomized in a 1:1 ratio to receive either a 0.25% bupivacaine– Clonidine (3 mcg/kg) mixture (CLONIDINE GROUP) or 0.25% bupivacaine alone (CONTROL GROUP) as anesthetic solution. Volume injected in both groups was 0.15ml/ kg/side. Demographics, type and duration of the procedure and intra and postoperative opioid consumption were recorded. Pain scores, incidence of delirium, respiratory and nerve block- related complications were recorded during the first 24 hrs.
RESULTS: Of the 119 patients analyzed, 65 (54.6%) were male, 54 (45.4%) underwent CP repair and 58 (48.7%) were 5 or less than 5 years old. Opioid consumption was lower in CP patients for the Clonidine group (17.2% Vs 48%; p=0.015). No intraoperative differences in hemodynamic parameters were observed. In the logistic regression model, use of Clonidine was related with a lower opioid consumption (OR 0.36; 95% CI 0.15-0.88; p=0.026) and a reduction of postoperative agitation (OR 0.26; 95% CI 0.09-0.80; p=0.018). There were no differences in postoperative complications between groups.
CONCLUSION: Clonidine 3 mcg/kg as adjuvant of bupivacaine for maxillary nerve block reduces opioid consumption and postoperative agitation after sevoflurane anesthesia in a mixed pediatric and adult population undergoing cleft surgery. Further studies are needed in order to assess more accurately the duration of analgesia using Clonidine as adjuvant for maxillary nerve block.


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