Comparison of Clonidine, Local Anesthetics, and Placebo for Pain Reduction in Pediatric Tonsillectomy

Moss, Jonathan R.; Cofer, Shelagh A.; Hersey, Shannon; Goudy, Steven L.; Werkhaven, Jay A.; Swanson, Erik; Mantle, Christopher; Stowell, Nicholas; Byrne, Daniel W.; Wang, Li; Labadie, Robert F.

doi:10.1001/archoto.2011.45

Cited by 11 publications

(3 citation statements)

References 19 publications

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“…A sample size of 154 subjects in the intent‐to‐treat (ITT) population, randomized in a 1 : 1 ratio into two treatment groups, was calculated to provide at least 80% power to detect a 0.75 dose reduction (>20% reduction in rescue analgesia) in the mean number of doses of postoperative fentanyl between patients receiving IV‐ibuprofen and those receiving placebo using a two‐sided Wilcoxon rank‐sum test assuming the mean number of doses in the placebo group is 3.5 at the significance level α = 0.05 and a standard deviation of 1.6 [based on reference and Moss JR, Cofer S, Hersey S, Goudy S, Werkhaven J, Swanson E, Mantle C, Stowell N, Byrne D, Wang L, Labadie R, unpublished data].…”

Section: Methodsmentioning

confidence: 99%

A multicenter, randomized, double‐blind placebo‐controlled, single dose trial of the safety and efficacy of intravenous ibuprofen for treatment of pain in pediatric patients undergoing tonsillectomy

Moss

Watcha

Bendel

et al. 2014

Pediatric Anesthesia

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Summary Background Tonsillectomy is one of the most common pediatric procedures in the United States. An optimal perioperative pain control regimen remains a challenge. Intravenous ibuprofen administered at induction of anesthesia may be a safe and efficacious option for postoperative tonsillectomy pain. Objectives To determine whether preoperative administration of intravenous ibuprofen (IV‐ibuprofen) can significantly decrease the number of doses of postoperative fentanyl when compared with placebo in pediatric tonsillectomy surgical patients. Methods This was a multicenter, randomized, double‐blind placebo‐controlled trial conducted at six hospitals in the United States. A total of 161 pediatric patients aged 6–17 years undergoing tonsillectomy were randomized to receive either a single preoperative dose of 10 mg·kg−1 IV‐ibuprofen or placebo (normal saline). Postoperative pain was managed with intravenous fentanyl (0.5 μg·kg−1) on an as needed basis when the visual analog scale (VAS) was >30 mm and deemed appropriate by recovery room nurse/physician. The primary endpoint was the number of doses and amount of postoperative fentanyl administered postoperatively for rescue analgesia. Results There was a significant reduction in the number of postoperative doses and the amount of fentanyl administered after surgery in the IV‐ibuprofen group compared with the placebo group (P = 0.021). There were no differences in the time to first analgesia request or the number of patients who required postoperative analgesia. There were no significant differences in the incidence of serious adverse events, surgical blood loss (P = 0.662), incidence of postoperative bleeding, or a need for surgical re‐exploration between the treatment groups. Conclusion Administration of IV‐ibuprofen, 10 mg·kg−1, significantly reduced fentanyl use in pediatric tonsillectomy patients.

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Section: Methodsmentioning

confidence: 99%

A multicenter, randomized, double‐blind placebo‐controlled, single dose trial of the safety and efficacy of intravenous ibuprofen for treatment of pain in pediatric patients undergoing tonsillectomy

Moss

Watcha

Bendel

et al. 2014

Pediatric Anesthesia

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“…or by infiltrating the a-2-adrenergic agonist locally. A recent study documented no analgesic effect of clonidine 25 µg infiltration when a basic analgesic regimen was used [53]. There was no study assessing systemic clonidine in this setting.…”

Section: Acupuncturementioning

confidence: 99%

PROSPECT guideline for tonsillectomy: systematic review and procedure‐specific postoperative pain management recommendations

et al. 2020

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Tonsillectomy is one of the most frequently performed surgical procedures; however, pain management remains challenging. Procedure-specific efficacy as well as specific risks of treatment options should guide selection of pain management protocols based on evidence and should optimise analgesia without harm. The aims of this systematic review were to evaluate the available literature and develop recommendations for optimal pain management after tonsillectomy. A systematic review utilising preferred reporting items for systematic reviews and meta-analysis guidelines with procedure-specific postoperative pain management (PROSPECT) methodology was undertaken. Randomised controlled trials published in the English language up to November 2019 assessing postoperative pain using analgesic, anaesthetic or surgical interventions were identified. Out of the 719 potentially eligible studies identified, 226 randomised controlled trials met the inclusion criteria, excluding the studies examining surgical techniques. Pre-operative and intra-operative interventions that improved postoperative pain were paracetamol; non-steroidal anti-inflammatory drugs; intravenous dexamethasone; ketamine (only assessed in children); gabapentinoids; dexmedetomidine; honey; and acupuncture. Inconsistent evidence was found for local anaesthetic infiltration; antibiotics; and magnesium sulphate. Limited evidence was found for clonidine. The analgesic regimen for tonsillectomy should include paracetamol; non-steroidal anti-inflammatory drugs; and intravenous dexamethasone, with opioids as rescue analgesics. Analgesic adjuncts such as intra-operative and postoperative acupuncture as well as postoperative honey are also recommended. Ketamine (only for children); dexmedetomidine; or gabapentinoids may be considered when some of the first-line analgesics are contra-indicated. Further randomised controlled trials are required to define risk and combination of drugs most effective for postoperative pain relief after tonsillectomy.

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“…A total of 189 randomized controlled and comparison trials met the inclusion criteria for analysis 18–206 . A PRISMA diagram outlining the literature search is shown in Figure 1, and the risk of bias graph is shown in Figure 2.…”

Section: Resultsmentioning

confidence: 99%

A scoping review of randomized clinical trials for pain management in pediatric tonsillectomy and adenotonsillectomy

Shih

Long

Pecha

et al. 2022

World j. otorhinolaryngol.-head neck surg.

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Comparison of Clonidine, Local Anesthetics, and Placebo for Pain Reduction in Pediatric Tonsillectomy

Abstract: clinicaltrials.gov Identifier: NCT00678379.

Cited by 11 publications

References 19 publications

A multicenter, randomized, double‐blind placebo‐controlled, single dose trial of the safety and efficacy of intravenous ibuprofen for treatment of pain in pediatric patients undergoing tonsillectomy

A multicenter, randomized, double‐blind placebo‐controlled, single dose trial of the safety and efficacy of intravenous ibuprofen for treatment of pain in pediatric patients undergoing tonsillectomy

PROSPECT guideline for tonsillectomy: systematic review and procedure‐specific postoperative pain management recommendations

A scoping review of randomized clinical trials for pain management in pediatric tonsillectomy and adenotonsillectomy

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