Pain Medications in Children Undergoing Strabismus Surgery

Status unconfirmed · Not applicable

Conditions studied: Pain, Nausea

In brief

Every year over 1,000 children undergo eye muscle surgery provided by physicians at this institution. For many of these children this is not and will not be the only surgical procedure for eye muscle correction. All of these children will experience differing degrees of postoperative pain. The pain associated with strabismus surgery is due to the manipulation in the conjunctival area and further handling of Tenon's capsule, sclera and the stretching of the eye muscle . Research has demonstrated that repeated painful procedures result in increased anxiety and increased pain. Previous studies have demonstrated that children experiencing preoperative anxiety are more likely to have increased postoperative pain . This increased preoperative anxiety may also contribute to sleep difficulties and increased analgesic consumption. Depending on the age of the child, different methods are used to reduce anxiety such as distraction, child life services, or anti-anxiolytic agents. In addition to pain, children undergoing strabismus surgery frequently experience postoperative nausea and vomiting (PONV).This increased incidence of nausea and vomiting is thought to be related to the use of opiates for pain control. Short acting opiates are used preferentially at this hospital in the belief that this reduces recovery issues of sedation and PONV. Preliminary data, however, suggests no difference in recovery outcomes for fentanyl versus hydromorphone. The purpose of this study is to investigate the optimal analgesia to create a standardized approach for pain management in pediatric patients undergoing surgery for strabismus.

Key facts

Study ID

NCT02789969

Run by

St. Louis Children's Hospital

People needed

128

Starts

2016-04-01

Expected to finish

2017-04-01

Last updated by the study team

2016-06-03

Who can join

Age: 3 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ages 3 to 10 years old having strabismus surgery for the first time, a repeated strabismus surgery, or an eye examination for strabismus under anesthesia;
• evaluated as an American Society of Anesthesiologists Physical Status (ASAPS) classification Class 1 or 2
• the caregiver should be present in the hospital
• the child and caregiver must be English speaking.

You may not qualify if…

• evaluated as an ASAPS Class 3 or 4
• non-English speaking children or parents
• additional surgery performed at the same time
• documented behavioral disabilities
• prior participation in the study.

Where it is running

• St. Louis Children's Hospital — St Louis, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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