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Pain Medications in Children Undergoing Strabismus Surgery

NCT02789969 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2016-06-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Hydromorphone

Hydromorphone 15mcg/kg IV

DRUG

Fentanyl

Fentanyl 1.5mcg/kg IV

Sponsors & Collaborators

  • St. Louis Children's Hospital

    lead OTHER

Principal Investigators

  • Hasima Hajdini, BSN · St. Louis Children's Hospital

  • Charles Schrock, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-03-31
Completion
2017-04-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02789969 on ClinicalTrials.gov