A randomized controlled trial of infraorbital block using ketamine 1% for intra- and postoperative analgesia in children for ambulatory cleft lip correction

Abstract

BACKGROUND In Indonesia, cleft lip correction surgery is often done as a social program in remote areas with limited resources. This study aimed to assess the effectiveness of ketamine, a cheaper and more accessible alternative, as a local analgesia in infraorbital block and to determine the possibility of ketamine as an alternative local analgesic drug for intraoperative and postoperative periods.
 METHODS This was a randomized controlled trial in children aged 2 months to 5 years who underwent cleft lip correction surgery at Cipto Mangunkusumo Hospital in 2016. Subjects were randomly divided into two groups: ketamine and bupivacaine. Standard general anesthesia with endotracheal intubation was performed in each group. Bilateral intraoral infraorbital block was performed using ketamine 1% 0.5 ml or bupivacaine 0.25% 0.5 ml. Postoperative evaluation includes pain scores based on the face, leg, activity, cry, and consolability (FLACC) scale and analgesic duration.
 RESULTS A total of 36 subjects were enrolled in this study, with 18 in each group. Both groups received the same total amount of fentanyl addition intraoperatively (p = 1). The postoperative FLACC pain scale scores between the two groups were not different, with p>0.05 in every measurement. The mean duration of postoperative analgesia in the ketamine group was longer than the bupivacaine group (15–13.49 hours, p = 0.031).
 CONCLUSIONS Infraorbital block with 1% ketamine 0.5 mg/kg was similarly effective for intraoperative and postoperative analgesia but had a longer duration than that with 0.25% bupivacaine 0.5 ml in ambulatory cleft lip correction.

Patient Safety and Quality Improvement Initiatives in Cleft Lip and Palate Surgery: A Systematic Review

“…Compared with IV pentazocine, Grewal et al32 found that infraorbital nerve block with 0.25% bupivacaine resulted in greater duration of analgesia (357.5versus 231 min; P <0.001), as well as fewer patients requiring supplementary analgesics (16.6% versus 76.6%). When compared with bilateral infraorbital nerve block with 1% ketamine (0.5 mL), Ramlan et al33 found that 0.25% bupivacaine (0.5 mL) resulted in similar pain scores, whereas ketamine provided a longer duration of analgesia ( P =0.031). Another study found morphine consumption to be lower ( P =0.033) in cleft palate patients receiving bilateral suprazygomatic maxillary nerve block with 0.15 mL/kg ropivacaine (0.2%) compared with saline 18.…”

“…Many of the included studies investigated the use of various analgesia techniques that aimed at reducing postoperative opioid consumption 2,14–29. Seven of the included studies investigated the effectiveness of bupivacaine for use in nerve block in cleft lip and/or palate repair 1,4,28,30–33. All but 11 focused on infraorbital nerve block placement in cleft lip surgery patients.…”

“…Compared with infraorbital nerve block with ketamine, however, bupivacaine was found to result in a shorter duration of analgesia, while still preserving similar pain scores. 33 Because of the relative ease of administration and apparent safety, infraorbital nerve blocks are generally now recommended for use in combination with general analgesia. Bupivacaine (0.25%) was the most cited agent used in infraorbital nerve blocks showing very few side effects while enhancing patient pain scores and various measures of analgesia ideals.…”

“…Ketamine may be beneficial for cleft repairs taking place in developing regions where bupivacaine is not easily accessible. 33 Still along the lines of pain control, one of the most common fears surrounding nonsteroidal anti-inflammatory (NSAID) use perioperatively is the possibility for increased risk of bleeding and hematoma formation due to the impairment of platelet aggregation. 69 Three of the included studies in this review found the incidence of adverse events, including perioperative bleeding, to be similar between placebo groups and diclofenac, acetaminophen, and ibuprofen groups, whereas pain scores and postoperative opioid requirements were found to be less in the treatment groups.…”

“…2,[14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29] Seven of the included studies investigated the effectiveness of bupivacaine for use in nerve block in cleft lip and/ or palate repair. 1,4,28,[30][31][32][33] All but 1 1 focused on infraorbital nerve block placement in cleft lip surgery patients. One found that when clonidine (3 μg/kg) was included with bupivacaine as an adjuvant in suprazygomatic maxillary nerve block for cleft lip and palate repair, emergence agitation was significantly reduced.…”