Clinical trial · Interventional
Pain Management After Transnasal Transsphenoidal Surgery for Pituitary Adenomas
Non-Steroidal Anti-inflammatory Drugs (NSAIDS) vs. Tramadol in Pain Management After Transnasal Transsphenoidal Surgery Among Patients With Pituitary Adenomas: A Prospective Randomized Controlled Trial
NCT04611685CI-TRIAL-00048052unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We hypothesize that the effects of non-steroidal anti-inflammatory drugs (NSAIDS) for pain relief among patients with pituitary adenomas undergoing transnasal transsphenoidal surgeries are non-inferior to tramadol. We aim to launch a single-center randomized clinical trial to verify this hypothesis.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
| Pituitary Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NSAID | Drug | — | UNRESOLVED |
| Tramadol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NSAIDs
- description
- Parecoxib (iv.) for once \& Loxoprofen (po.) for routine use during the first 3 postop. days.
- interventionNames
- Drug: NSAID
- type
- ACTIVE_COMPARATOR
- label
- Tramadol
- description
- Tramadol (im.) for once \& Tramcontin (po.) for routine use during the first 3 postop. days.
- interventionNames
- Drug: Tramadol
Primary outcomes (1)
- measure
- The VAS scores of patients
- timeFrame
- 24 hours after the surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with pituitary adenomas that need transnasal transsphenoidal surgery * Patients of either gender aged 18 to 70 years Exclusion Criteria: * Patients with rhinitis, sinusitis, deviated nasal septum, etc. that can cause nasal pain * Patients with medical history of digestive ulcer/gastrointestinal bleeding * Patients with heart disease, severe liver and kidney dysfunction * Pregnant patients * Patients allergic to NSAIDs or tramadol * Patients who need long-term treatment of NSAIDs or analgesic for other reasons * Patients whose postoperative paraffin pathology suggests non-pituitary adenoma * Patients who have not undergone transsphenoidal surgery * Patients who reject to enter the group or ask to leave the group after entry
References
Publications (5)
- BACKGROUNDTitsworth WL, Abram J, Guin P, Herman MA, West J, Davis NW, Bushwitz J, Hurley RW, Seubert CN. A prospective time-series quality improvement trial of a standardized analgesia protocol to reduce postoperative pain among neurosurgery patients. J Neurosurg. 2016 Dec;125(6):1523-1532. doi: 10.3171/2015.10.JNS15698. Epub 2016 Mar 11. PMID 26967774
- BACKGROUNDQuiney N, Cooper R, Stoneham M, Walters F. Pain after craniotomy. A time for reappraisal? Br J Neurosurg. 1996 Jun;10(3):295-9. doi: 10.1080/02688699650040179. PMID 8799542
- BACKGROUNDJoshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. doi: 10.1016/j.atc.2004.11.013. PMID 15763409
- BACKGROUNDShepherd DM, Jahnke H, White WL, Little AS. Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery. J Neurosurg. 2018 Feb;128(2):444-451. doi: 10.3171/2016.10.JNS161355. Epub 2017 Mar 3. PMID 28298041
- BACKGROUNDMolitch ME. Diagnosis and Treatment of Pituitary Adenomas: A Review. JAMA. 2017 Feb 7;317(5):516-524. doi: 10.1001/jama.2016.19699. PMID 28170483