Remifentanil Tapering and Post-adenotonsillectomy Pain in Children
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Child, Only
- Pain
- Remifentanil
- Tonsillectomy
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Double blind, randomised, placebo controlled trial.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Two syringes will be simultaneously infused during the operation. One will contain normal saline solution and the other remifentanil solution. Prior to the end of the operation one of the syringes will have a step wise decrease in infusion rate whilst the other will be abruptly stopped at the end of surgery. The syringes will be prepared according to randomisation in the hospital pharmacy and the identity of each syringe will be masked from all those involved in the study. The syringe randomisation will be de-coded following completion of recruitment.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 1 years and 10 years
- Gender
- Both males and females
Description
Tonsillectomy is one of the commonest childhood operations in the world; approximately 9200 children have their tonsils removed every year in Norway alone. Postoperative pain following the procedure is significant and notoriously difficult to mange. It´s management is potentially complicated by naus...
Tonsillectomy is one of the commonest childhood operations in the world; approximately 9200 children have their tonsils removed every year in Norway alone. Postoperative pain following the procedure is significant and notoriously difficult to mange. It´s management is potentially complicated by nausea and the risk of tonsillar infection or re-bleeding. Post-tonsillectomy pain in children is persistent, with 75% of children experiencing significant pain for the first three days and 50% still suffering with significant pain one week after the procedure. As well as delaying recovery, reducing oral intake of food and drink and disturbing sleep, post tonsillectomy pain has been shown to result in more than 50% of patients and their parents consulting their primary care physician in the post operative period, with the ensuing costs to the families and healthcare providers. It is worth noting, that despite significant postoperative pain and potential complications, recovery after adeno / tonsillectomy is excellent. The operative nature of tonsillectomy and adenotonsillectomy necessitates the provision of general anaesthesia to the child. The technique must ensure sufficient depth of anaesthesia and analgesia and protection of the airway from blood and surgical debris. Whilst there are a wide variety of anaesthetic techniques employed to achieve these goals,Total Intra Venous Anaesthesia (TIVA) with propofol and remifentanil has been shown in previous studies to be superior to volatile based (gas) anaesthesia, resulting in less post operative nausea and vomiting, less long term adverse behavioural changes, improved quality of emergence from anaesthesia, and less environmental pollution. The use of remifentanil and propofol TIVA in children is well established and has been in use since at least the year 2000 for children undergoing tonsillectomy. Despite this the effects of remifentanil dosing on post-operative pain has not been studied in children undergoing tonsillectomy, though it may play a significant role.
Tracking Information
- NCT #
- NCT03994146
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Signe Søvik, MD. PhD University Hospital, Akershus
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