Recruiting

Pain Medications

Sponsor:

St. Louis Children's Hospital

Code:

NCT02789969

Conditions

Pain

Nausea

Eligibility Criteria

Sex: All

Age: 3 - 10

Healthy Volunteers: Not accepted

Interventions

Hydromorphone

Fentanyl

Study Details

Brief 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

Pain

Nausea

Study ID

NCT02789969

Start date

Apr, 2016

Status verified date

Jun, 2016

Completion date

Apr, 2017

Anticipated

Primary completion date

Mar, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 10

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hydromorphone 15mcg/kg IV

Patient randomly assigned to hydromorphone

experimental: Fentanyl 1.5 mcg/kg IV

Patient randomly assigned to fentanyl

Interventions

Hydromorphone

Hydromorphone 15mcg/kg IV

Fentanyl

Fentanyl 1.5mcg/kg IV

Primary outcome measure

  • Change in pain measured by the rFLACC scale [ Time Frame: every 15 minutes for 2 hours and 24 hours after discharge ]

Central Contacts and Locations

Central contacts

Lisa Steurer, Phd(c)

314-608-2249lmi8177@bjc.org

Locations

St. Louis Children's Hospital

Recruiting

St. Louis, Missouri, United States, 63110

Contacts

Lisa Steurer, PhD(c)

314-454-4528lmi8177@bjc.org

More Information

Sponsor

St. Louis Children's Hospital

Last update posted

Jun 3, 2016

Last verified

Jun, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Louis Children's Hospital on 2016-06-03.