Dexamethasone or Clonidine as Adjuncts to Ropivacaine for Caudal Analgesia on Analgesia Duration in Children

Postoperative Pain Clinical Trial

Official title:

Effect of Dexamethasone or Clonidine When Given as Adjuncts to Ropivacaine for Caudal Analgesia on Duration of Analgesia Compared to Placebo in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02773602
• Other study ID #: HSC-MS-11-0002
• Status: Recruiting
• Phase: Phase 4
• First received: December 11, 2015
• Last updated: May 12, 2016
• Start date: May 2011
• Est. completion date: December 2017

Study information

• Verified date: May 2016
• Source: The University of Texas Health Science Center, Houston
• Contact: Emad m. Sorial, (M.B; B.CH).
• Phone: +1-713-500-6186
• Email: emad.m.sorial[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparing the duration of pain relief from caudal analgesia when adjuncts like dexamethasone, clonidine, or saline (salt water) are added to ropivacaine.

Description:

The local anesthetic, which is currently used for caudal analgesia, is called ropivacaine. It works well and is safe in infants and children. Doctors commonly add small amounts of other medication to ropivacaine to prolong the duration of pain relief provided by a single injection of caudal analgesia.

In this study, the length of duration of pain relief the child receives from caudal analgesia will be examined when different medications are added to ropivacaine. Specifically, dexamethasone, clonidine, or saline (salt water) will be added to ropivicaine and the length of time it takes before the child needs more pain medication will be determined.

Clonidine has been added to caudal analgesia for infants and children for many years. It increases the duration of pain relieving effect of ropivicaine by itself, however, it may lead to prolonged sedation following the surgical procedure (an undesired effect) and it is expensive.

Dexamethasone has been used for adult epidurals and nerve blocks and in spine surgeries. It prolongs the duration of pain relief and causes less sedation. It is commonly administered to children during surgery to help decrease nausea and vomiting after surgery. It is also much cheaper than clonidine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

Inclusion Criteria:

• The subject will receive presurgical caudal block

• American Society of Anesthesiologists (ASA) 1 or 2

• Day surgery unit

• weight 30 kg or less

Exclusion Criteria:

• Neuromuscular disease

• Back problem

• Caudal area skin infection

• Mental retardation

• Developmental delay

• Bleeding disorder

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexamethasone
200 µgm/kg of dexamethasone in 1 ml saline
• Clonidine
2 µg/kg of clonidine in 1 ml saline
• Normal Saline
1 ml of saline added to the ropivacaine, 0.2%, 1 ml/kg

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of block	Duration of block is calculated from time of first pain medication minus time of caudal placement. Caudal placement occurs before pain medication is administered.	Within 24 hours after surgery
Secondary	Number of children between the groups who received pain medication in the PACU		Within 24 hours after surgery
Secondary	Number of children between the groups who received pain medication after hospital discharge		Within 24 hours after surgery
Secondary	number of children group between the groups who required pain medication in first 24 h after surgery		Within 24 hours after surgery
Secondary	Awakening time	Awakening time is calculated from the end of anesthesia to time to reach Steward Score of 6. Patients who are awake, coughing/crying, and have purposeful movements are assigned a Steward Score of 6.	Within 24 hours after surgery