Acetaminophen + Ketorolac for Pain Management During Lithotripsy

This trial tests whether a non-opioid pain relief method is as effective as or better than opioid-based pain relief during extracorporeal shockwave lithotripsy (ESWL), a procedure for treating kidney stones. Participants will receive either a non-opioid combination of intravenous acetaminophen and ketorolac or an opioid-based treatment with fentanyl, both paired with the sedative midazolam. The study evaluates how well each treatment manages pain and whether the non-opioid option results in fewer side effects. This trial suits adults scheduled for ESWL who have not used narcotics in the last 48 hours. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used narcotics in the last 48 hours or if you are on anticoagulants.

Research has shown that both acetaminophen and ketorolac effectively relieve pain. Studies found that intravenous ketorolac can provide better pain control than acetaminophen alone. However, both medications work well and are often combined to relieve pain.

Intravenous acetaminophen and ketorolac are generally well-tolerated in terms of safety. Most people do not experience serious side effects. Common side effects might include minor issues like nausea or dizziness, but these are usually not severe. The trial's later phase indicates that the safety of this combination is well understood and acceptable.

Researchers are excited about using intravenous acetaminophen and ketorolac for pain management during lithotripsy because these treatments offer a non-opioid alternative to traditional pain relief methods, which often rely on opioids. Acetaminophen and ketorolac work through different pathways to manage pain—acetaminophen acts on the central nervous system while ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) that reduces inflammation and pain. This combination has the potential to effectively manage pain without the risk of addiction associated with opioids, making it a promising option for patients undergoing lithotripsy.

Research has shown that using intravenous acetaminophen and ketorolac together can effectively manage pain. Studies have found that ketorolac reduces pain levels more than acetaminophen in cases of severe pain. In this trial, one group will receive a combination of acetaminophen and ketorolac, which has reduced the need for opioid drugs like fentanyl by 61%, leading to fewer opioid-related side effects. This suggests that using acetaminophen and ketorolac without opioids may provide effective pain relief during procedures like extracorporeal shockwave lithotripsy (ESWL).¹⁵⁶⁷⁸