Pain Medications in Children Undergoing Strabismus Surgery

NCT02789969 | Unknown

• 1 other identifier: 201602156
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in pain measured by the rFLACC scale

  every 15 minutes for 2 hours and 24 hours after discharge

Secondary Outcomes (2)

• nausea measured by self-report

  every 15 minutes for 2 hours and 24 hours after discharge

• Parental anxiety measured by Amsterdam Preoperative Anxiety and Information Scale

  1 time preoperatively 1 hour before surgery

Study Arms (2)

Hydromorphone 15mcg/kg IV

EXPERIMENTAL

Patient randomly assigned to hydromorphone

Drug: Hydromorphone

Fentanyl 1.5 mcg/kg IV

EXPERIMENTAL

Patient randomly assigned to fentanyl

Drug: Fentanyl

Interventions

Hydromorphone DRUG

Hydromorphone 15mcg/kg IV

Also known as: Dilaudid

Hydromorphone 15mcg/kg IV

Fentanyl DRUG

Fentanyl 1.5mcg/kg IV

Also known as: Sublimaze

Fentanyl 1.5 mcg/kg IV

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• St. Louis Children's Hospital: lead

Study Sites (1)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (9)

• Noel M, McMurtry CM, Chambers CT, McGrath PJ. Children's memory for painful procedures: the relationship of pain intensity, anxiety, and adult behaviors to subsequent recall. J Pediatr Psychol. 2010 Jul;35(6):626-36. doi: 10.1093/jpepsy/jsp096. Epub 2009 Nov 4.

  PMID: 19889718 BACKGROUND

• Bakr RH, Abdelaziz HM. SUBTENON BUPIVACAINE INJECTION FOR POSTOPERATIVE PAIN RELIEF FOLLOWING PEDIATRIC STRABISMUS SURGERY: A RANDOMIZED CONTROLLED DOUBLE BLIND TRIAL. Middle East J Anaesthesiol. 2015 Feb;23(1):91-9.

  PMID: 26121900 BACKGROUND

• Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.

  PMID: 16882820 BACKGROUND

• Chieng YJ, Chan WC, Klainin-Yobas P, He HG. Perioperative anxiety and postoperative pain in children and adolescents undergoing elective surgical procedures: a quantitative systematic review. J Adv Nurs. 2014 Feb;70(2):243-55. doi: 10.1111/jan.12205. Epub 2013 Jul 19.

  PMID: 23865442 BACKGROUND

• Chieng YJ, Chan WC, Liam JL, Klainin-Yobas P, Wang W, He HG. Exploring influencing factors of postoperative pain in school-age children undergoing elective surgery. J Spec Pediatr Nurs. 2013 Jul;18(3):243-52. doi: 10.1111/jspn.12030. Epub 2013 Apr 23.

  PMID: 23822848 BACKGROUND

• Brasher C, Gafsous B, Dugue S, Thiollier A, Kinderf J, Nivoche Y, Grace R, Dahmani S. Postoperative pain management in children and infants: an update. Paediatr Drugs. 2014 Apr;16(2):129-40. doi: 10.1007/s40272-013-0062-0.

  PMID: 24407716 BACKGROUND

• He HG, Zhu L, Chan SW, Klainin-Yobas P, Wang W. The effectiveness of therapeutic play intervention in reducing perioperative anxiety, negative behaviors, and postoperative pain in children undergoing elective surgery: a systematic review. Pain Manag Nurs. 2015 Jun;16(3):425-39. doi: 10.1016/j.pmn.2014.08.011.

  PMID: 26025800 BACKGROUND

• He HG, Zhu L, Li HC, Wang W, Vehvilainen-Julkunen K, Chan SW. A randomized controlled trial of the effectiveness of a therapeutic play intervention on outcomes of children undergoing inpatient elective surgery: study protocol. J Adv Nurs. 2014 Feb;70(2):431-42. doi: 10.1111/jan.12234. Epub 2013 Aug 29.

  PMID: 23991679 BACKGROUND

• Chhabra A, Pandey R, Khandelwal M, Subramaniam R, Gupta S. Anesthetic techniques and postoperative emesis in pediatric strabismus surgery. Reg Anesth Pain Med. 2005 Jan-Feb;30(1):43-7. doi: 10.1016/j.rapm.2004.08.023.

  PMID: 15690267 BACKGROUND

MeSH Terms

Conditions

Pain; Nausea

Interventions

Hydromorphone; Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Hasima Hajdini, BSN

  St. Louis Children's Hospital

  PRINCIPAL INVESTIGATOR

• Charles Schrock, MD

  Washington University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Lisa Steurer, Phd(c)

CONTACT

314-608-2249; lmi8177@bjc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: June 3, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: June 3, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)