A randomized, double-blinded, placebo-controlled, single dose analgesic study of preoperative intravenous ibuprofen for tonsillectomy in children
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Published on: November 6, 2019
Xiaohuan Cui1, Jianmin Zhang1, Zhengzheng Gao1
1Department of Anesthesiology, National Center for Children's Health, Beijing Children's Hospital, Capital Medical University, Beijing, China.
Insights
Intravenous ibuprofen administered before tonsillectomy significantly reduced the need for rescue fentanyl in children. This safe, effective approach can be a key part of managing pain after pediatric tonsillectomy.
Area of Science:
- Pediatric Anesthesiology
- Pain Management
- Pharmacology
Background:
- Tonsillectomy in children often leads to significant postoperative pain, commonly managed with opioids like fentanyl.
- Opioids are associated with adverse effects including nausea, vomiting, and respiratory depression.
- Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, offer a potentially safer alternative for pain management.
Purpose of the Study:
- To evaluate the efficacy and safety of adding intravenous (IV) ibuprofen at induction to reduce early postoperative analgesic requirements in pediatric tonsillectomy patients.
- To compare the need for rescue analgesia between children receiving IV ibuprofen and those receiving a placebo.
Main Methods:
- A randomized, double-blind, controlled trial involving 95 pediatric patients (6 months to 12 years) undergoing tonsillectomy.
- Participants received either IV ibuprofen (10 mg kg⁻¹) or placebo 15 minutes before surgery.
- Pain was assessed using the FLACC scale and visual analog scale, with rescue IV fentanyl administered as needed.
Main Results:
- The requirement for rescue fentanyl was reduced by 18% in the IV ibuprofen group compared to placebo (P=0.043).
- No significant differences were observed in the total amount of fentanyl administered or in operative blood loss, vomiting, or postoperative bleeding.
- Fewer children in the ibuprofen group required more than one dose of rescue fentanyl, though this did not reach statistical significance (P=0.056).
Conclusions:
- Administering IV ibuprofen 15 minutes prior to tonsillectomy is safe and significantly decreases the need for rescue fentanyl.
- IV ibuprofen represents a valuable component of multimodal analgesia for pediatric tonsillectomy.
- This strategy should be considered for optimizing postoperative pain management in children.
Purpose:
Tonsillectomy is a recognized treatment for children with tonsil hypertrophy and results in significant postoperative oropharyngeal pain. Fentanyl and other morphine-like analgesics are widely used as perioperative analgesia but are associated with side effects such as vomiting, nausea, and respiratory depression. As the least toxic non-steroidal anti-inflammatory drug, ibuprofen may be effective and safe for pain control after tonsillectomy. We aimed to explore whether the addition of intravenous (IV) ibuprofen administered at induction can reduce the need for early postoperativeanalgesics.
Study Design And Methods:
This randomized, double-blind, controlled clinical trial enrolled 95 pediatric patients who underwent tonsillectomy. Participants aged 6 months to 12 years were randomly assigned to either the experimental and control groups (1:1). The children were premedicated 15 min before surgery with IV ibuprofen 10 mg kg-1 or placebo (normal saline). Pain was scored at 15, 30, and 120 min after extubation, and IV fentanyl (0.5 mcg kg-1) was administered when the Faces, Legs, Activity, Cry, and Consolability (FLACC) Scale was ≥7 and deemed appropriate by the nursing staff in the post-anesthesia care unit (PACU). The visual analog scale was used as a supplementary evaluation for older children (≥7 years old) who were awake and could self-report pain. The primary outcome variable was the number of patients who received postoperative analgesia.
Results:
The requirement for rescue fentanyl was reduced by 18% with the addition of IV ibuprofen (P = 0.043). There were no signficant differences in the amount of fentanyl administered postoperatively (P = 0.127). Compared with the placebo group, the number of children who needed more than one dose of rescue fentanyl decreased in the experimental group, but the differences were not significant (P = 0.056). There were no significant differences between the groups in terms of operative blood loss (P = 0.978), vomiting, or postoperative bleeding (P = 0.474).
Conclusion:
It is safe to administer IV ibuprofen 15 min before tonsillectomy, and it can significantly reduce the need for rescue fentanyl. IV ibuprofen should be considered as an important part of the multimodal approach for postoperative analgesia in children.
Clinical Trial Registration:
Chictr.org.cn, identifier: ChiCTR2100044508.
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