Low Dose IV Dexamethasone in Prolonging Caudal Anesthesia in Children Undergoing Genitourinary Surgery

Surgery Clinical Trial

Official title:

Low Dose IV Dexamethasone in Prolonging Caudal Anesthesia in Children Undergoing Genitourinary Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02436265
• Other study ID #: 1408968524
• Status: Terminated
• Phase: Phase 4
• Start date: February 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2021
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Caudal injection of local anesthetic is a neuraxial technique routinely performed on young children for postoperative analgesia after lower abdominal and lower extremity surgical procedures. One of the major limitations of the use of single shot neuraxial injections for this purpose is the limited duration of action of the injected local anesthetic. Adjuvant medications, such as clonidine and epinephrine, have been added to the local anesthetic to prolong the duration of the neuraxial block, with varying results. Dexamethasone is a synthetic glucocorticoid steroid commonly used in the perioperative setting for a multitude of indications, including the prolongation of local anesthetic based analgesia. It has been shown that the administration of dexamethasone either intravenously or via perineural injection can significantly increase the duration of analgesia derived from a local anesthesia based peripheral nerve block. Literature also suggests that the effect of dexamethasone is equivalent whether given intravenously or perineurally. Interest in dexamethasone enhanced caudal analgesia exists and a previous study noted that caudal anesthesia can be prolonged by intravenous dexamethasone. The study was criticized for using a higher dose of dexamethasone (0.5 mg/kg) than is routinely used in the pediatric population outside of airway procedures, which may expose patients to dose related side effects of dexamethasone. A large meta-analysis has suggested that 0.1 mg/kg is effective for analgesic prolongation, but no direct study of low dose intravenous dexamethasone in combination with caudal anesthesia has been performed.

Description:

As dexamethasone is an inexpensive and commonly used medication, it would be beneficial to know if a similar prolongation of analgesia occurs when a local anesthetic is given neuraxially in combination with low dose intravenous dexamethasone. This project will investigate the efficacy of low dose intravenous (IV) dexamethasone in prolonging the duration of post operative analgesia provided by an intraoperative caudal injection of local anesthetic. All patients will be enrolled in the study the day of surgery, in the preoperative waiting area. The study will be explained by an anesthesiologist with extensive knowledge of the protocol. Computer randomization will occur for each patient. Randomization will not increase the risk to either group as all medications and techniques utilized for this study are commonly accepted for routine care for these patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2017
• Est. primary completion date: June 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

Inclusion Criteria:

• age 2 to 10 years
• Scheduled for elective inpatient genitourinary surgical procedure
• Caudal anesthesia standard of care for surgical procedure
• have provided parental consent and assent in accordance with the institutional review board requirements

Exclusion Criteria:

• Abnormal/difficult anatomy
• known allergy to ropivacaine or dexamethasone
• history of documented chronic pain
• existing infection at site of intended injection

Related Conditions & MeSH terms

• Surgery

Intervention

Drug:
• Dexamethasone
IV dexamethasone
• Ropivacaine
Ropivacaine only

Locations

Country	Name	City	State
United States	Riley Hospital for Children	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (3)

De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2. Review. — View Citation

Desmet M, Braems H, Reynvoet M, Plasschaert S, Van Cauwelaert J, Pottel H, Carlier S, Missant C, Van de Velde M. I.V. and perineural dexamethasone are equivalent in increasing the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder surgery: a prospective, randomized, placebo-controlled study. Br J Anaesth. 2013 Sep;111(3):445-52. doi: 10.1093/bja/aet109. Epub 2013 Apr 15. — View Citation

Hong JY, Han SW, Kim WO, Kim EJ, Kil HK. Effect of dexamethasone in combination with caudal analgesia on postoperative pain control in day-case paediatric orchiopexy. Br J Anaesth. 2010 Oct;105(4):506-10. doi: 10.1093/bja/aeq187. Epub 2010 Jul 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Pain Scores Over 24 Hours	Will track the trend of pain scores for both arms to note differences in pain score based on intervention received. Pain scores will be based on a patient verbal response of 0-10 pain, 0 being no pain and 10 being worst pain, or with a FLACC score (Face, Legs, Activity, Cry, Consolability scale) of 0-10 if patient unable to communicate verbally	24 hours