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Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Tonsillectomy or Adeno-tonsillectomy in Children

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ClinicalTrials.gov Identifier: NCT02205580
Recruitment Status : Unknown
Verified September 2014 by Jin Ni, Guangzhou Women and Children's Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : July 31, 2014
Last Update Posted : September 30, 2014
Sponsor:
Information provided by (Responsible Party):
Jin Ni, Guangzhou Women and Children's Medical Center

Brief Summary:

Postoperative pain following tonsillectomy or adeno-tonsillectomy in children is severe and sometimes last for days. Sufentanil is used by epidural route for postoperative analgesia in children. There are few reports about its use for postoperative analgesia by continuous intravenous infusion. Its complications include , hypoxia, sedation, pruritus ,nausea and/or vomiting.

The investigators design this protocol to test efficacy of analgesia of three different rates of continuous intravenous sufentanil infusion for postoperative pain management following coblation tonsillectomy or adeno-tonsillectomy in children. The investigators also compare incidence rate of complications for three groups.


Condition or disease Intervention/treatment Phase
Sleep Breathing Disorders Tonsillitis Adenoid Hypertrophy Drug: continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion Drug: continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion Drug: continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Three Different Rates of Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Coblation Tonsillectomy or Adeno-tonsillectomy in Children
Study Start Date : September 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sufentanil infusion rate 0.02μg•kg-1•h-1
Sufentanil infusion rate 0.02μg•kg-1•h-1 lasted for 48 hours
Drug: continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion
Experimental: Sufentanil infusion rate 0.03μg•kg-1•h-1
Sufentanil infusion rate 0.03μg•kg-1•h-1 lasted for 48 hours
Drug: continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion
Experimental: Sufentanil infusion rate 0.04μg•kg-1•h-1
Sufentanil infusion rate 0.04μg•kg-1•h-1 lasted for 48 hours
Drug: continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion



Primary Outcome Measures :
  1. objective pain score [ Time Frame: up to 48 hours after operation ]

Secondary Outcome Measures :
  1. incidence rate of hypoxia [ Time Frame: 4h,8h,24h,48h after operation ]

Other Outcome Measures:
  1. incidence rate of pruritus [ Time Frame: 4h,8h,24h,48h after operation ]
  2. incidence rate of nausea and/or vomiting [ Time Frame: 4h,8h,24h,48h after operation ]
  3. incidence rate of sedation [ Time Frame: 4h,8h,24h,48h after operation ]


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Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists grade I or II children aged 5-8 years undergoing coblation tonsillectomy or adeno-tonsillectomy as in-patient

Exclusion Criteria:

  • Children with a history of adverse reaction to opioids, long-term use of opioid medications, and history of chronic pain.
  • Psychiatric illness, kidney failure, hypotension, atrioventricular block, myasthenia gravis etc.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205580


Locations
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China, Guangdong
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China, 510623
Sponsors and Collaborators
Jin Ni
Investigators
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Principal Investigator: Jin Ni, M.D. Guangzhou Women and Children's Medical Center

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Responsible Party: Jin Ni, Department of Anesthesiology, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier: NCT02205580     History of Changes
Other Study ID Numbers: GZWCMC
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Tonsillitis
Pain, Postoperative
Hypertrophy
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Respiratory Tract Diseases
Pathological Conditions, Anatomical
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Sufentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics