Individualized Analgesia After Adenotonsillectomy

• ClinicalTrials.gov Identifier: NCT02990910
• Recruitment Status: Completed
• First Posted: December 13, 2016
• Results First Posted: August 9, 2017
• Last Update Posted: July 21, 2020
• Sponsor: Children's Hospital of Fudan University
• Information provided by (Responsible Party): Xuan Wang, Children's Hospital of Fudan University

Study Description

Brief Summary:

A high incidence of respiratory morbidity after adenotonsillectomy is reported in children with obstructive sleep apnea syndrome (OSAS). So we designed a prospective, double-blind, randomized controlled study to determine the effects of individualized opioid analgesia compared with conventional opioid analgesia on respiratory morbidity after adenotonsillectomy in Children with OSAS.

Condition or disease	Intervention/treatment	Phase
Analgesia	Drug: Individualized opioid analgesia; Device: conventional opioid analgesia	Not Applicable

Detailed Description:

All children were randomized 2 groups based on a computer-generated random number. The main interventions were occurred in post anesthetic care unit (PACU). In the operating room, all patients received a standardized anesthetic regimen by one anesthetist. Sevoflurane was used for maintenance without any opioids. Before the end of the procedure, spontaneous respiratory was recovered. All the patients were given 1 mcg/kg fentanyl intravenous injection after the end of the procedure. The positive result was defined as spontaneous respiratory rate decreased more than 50%, the others were defined as negative result. The result of fentanyl test submitted to assistant, and prepared the rescue analgesic drugs according to this result. One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine. Another group: all received 25μg/kg morphine .The trachea was extubated when patients were awake, and then transported to the PACU. Patients with a Children's Hospital of Eastern Ontario Pain Scale score>6 received rescue analgesic drugs and observe respiratory morbidity in each group.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 280 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effects of an Individualized Analgesia Protocol on the Requirements of Medical Interventions After Adenotonsillectomy in Children Based on the Result of a Fentanyl Test: a Randomized Controlled Trial
• Actual Study Start Date: November 2016
• Actual Primary Completion Date: February 2017
• Actual Study Completion Date: February 2017

Arms and Interventions

Arm	Intervention/treatment
Individualized opioid analgesia; One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.	Drug: Individualized opioid analgesia; (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.; Other Name: IP
conventional opioid analgesia; Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9.	Device: conventional opioid analgesia; (b) all received 25μg/kg morphine; Other Name: CP

Outcome Measures

Primary Outcome Measures :

1. The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events [ Time Frame: Time from entering the PACU until the patient leaves,approx 1 hour. ]
   The medical interventions included instrumentation of the airway, bag/mask ventilation, and/or drug administration (succinylcholine, albuterol, or naloxone), which were classified as major medical interventions. The medical interventions also included repositioning of the child's airway, chin lift/jaw thrust maneuvers, and/or escalating to an oxygen mask, which were classified as minor medical interventions. Since oxygen by nasal cannula was delivered to all children recovering from anesthesia, escalating to an oxygen mask implied the patient need but higher concentration of oxygen to maintain SpO2 ≥ 95%.

Secondary Outcome Measures :

1. The Median Survival Time for CHEOPS Score > 6. [ Time Frame: Time from entering the PACU until the patient leaves,approx 1 hour. ]
   Pain was assessed and recorded through the East Ontario children's hospital pain score (CHEOPS).When the CHEOPS>6,We thought it is painful. Comparing the median survival time (the time corresponding to pain percentage of 50% in two groups) for CHEOPS>6 in two groups.

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 10 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• children with obstructive sleep apnea syndrome undergoing elective T&A, ASA physical status I-II

Exclusion Criteria:

• developmental delay cardiac and craniofacial abnormalities ASA classification III or more body mass index more than the 95th percentile for age

Contacts and Locations

Locations

China, Shanghai

Chilren's Hospital of Fudan University

Shanghai, Shanghai, China, 201102

Sponsors and Collaborators

Children's Hospital of Fudan University

Investigators

• Principal Investigator: xuan wang; Children's Hospital of Fudan University

  Study Documents (Full-Text)

Documents provided by Xuan Wang, Children's Hospital of Fudan University:

Statistical Analysis Plan  [PDF] February 15, 2017

Informed Consent Form  [PDF] February 15, 2017

Study Protocol  [PDF] February 15, 2017

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Guo J, Zhuang P, Liu K, Wan Y, Wang X. Effects of an individualized analgesia protocol on the need for medical interventions after adenotonsillectomy in children: a randomized controlled trial. BMC Anesthesiol. 2021 Feb 8;21(1):41. doi: 10.1186/s12871-021-01263-3.

• Responsible Party: Xuan Wang, Doctor, Children's Hospital of Fudan University
• ClinicalTrials.gov Identifier: NCT02990910
• Other Study ID Numbers: IARA
• First Posted: December 13, 2016
• Results First Posted: August 9, 2017
• Last Update Posted: July 21, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xuan Wang, Children's Hospital of Fudan University:

respiratory adverse events; adenotonsillectomy; opioid analgesia; children

Additional relevant MeSH terms:

Agnosia; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents